Trial Outcomes & Findings for Pharmacokinetics and Safety of SAR441236 (NCT NCT03705169)

Last Updated: 2024-01-12

Results Overview

The proportion of participants reporting a grade 3 (severe), grade 4 (potentially life-threatening), or grade 5 (death) adverse event, that was judged by the core safety team (blinded to active/placebo treatment in Arms A and C) to be at least possibly related to study treatment. Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

52 participants

Primary outcome timeframe

Measured from Day 0 through entire study follow-up, up to 24 weeks post study treatment administration for single dose cohorts (all arms) and up to 36 weeks after the fourth study treatment administration for the multi-dose cohort (Arm A only).

Results posted on

2024-01-12

Participant Flow

Participants were enrolled at 23 Clinical Research Sites (CRSs) in the United States between May 2019 and October 2021.

Participants who enrolled in Arms A and C were randomized 2:1 SAR441236:placebo. Participants who enrolled in Arm B were not randomized and were assigned open-label SAR4412326. For analysis, participants receiving placebo (of any dose-volume equivalent) are pooled within arm per the pre-specified analysis plan.

Participant milestones

Participant milestones
Measure	Arm A: 1 mg/kg SAR441236 Participants continued on non-study-provided ART and received 1 mg/kg of SAR441236, administered as a single intravenous (IV) infusion on Day 0 (Cohort 1). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 3 mg/kg for SAR441236 Experimental: Arm A: 3 mg/kg SAR441236 Participants continued on non-study-provided ART, and received 3 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 2). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 10 mg/kg SAR441236 Participants continued non-study-provided ART and received 10 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 3). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 30 mg/kg SAR441236 Participants continued non-study-provided ART and received 30 mg/kg of SAR441236, administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 0 mg/kg SAR441236 Placebo participants were pooled across those receiving: * 1 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 1). * 3 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 2). * 10 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 3) * 30 mg/kg dose volume-equivalent administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4) All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 1 mg/kg SAR441236 Participants received 1 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 5). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 30 mg/kg SAR441236 Participants received 30 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 8). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0.3 mg/kg SAR441236 Participants continued non-study-provided ART and received 0.3 mg/kg of SAR441236, administered as a subcutaneous (SC) injection(s) on Day 0 (Cohort 10). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 1 mg/kg SAR441236 Participants continued non-study-provided ART and received 1 mg/kg of SAR441236, administered as an SC injection(s) on Day 0 (Cohort 11). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0 mg/kg SAR441236 Placebo participants were pooled across those receiving: * 0.3 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 10). * 1 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 11). All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)
Overall Study STARTED	4	4	4	11	10	5	2	4	4	4
Overall Study Participants Receiving First Dose	4	4	4	10	10	5	2	4	4	4
Overall Study COMPLETED	4	4	4	5	10	3	1	4	4	3
Overall Study NOT COMPLETED	0	0	0	6	0	2	1	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A: 30 mg/kg SAR441236 Participants continued non-study-provided ART and received 30 mg/kg of SAR441236, administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 1 mg/kg SAR441236 Participants received 1 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 5). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 30 mg/kg SAR441236 Participants received 30 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 8). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0 mg/kg SAR441236 Placebo participants were pooled across those receiving: * 0.3 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 10). * 1 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 11). All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)
Overall Study Lost to Follow-up	2	2	1	1
Overall Study Adverse Event	1	0	0	0
Overall Study Site Closure	1	0	0	0
Overall Study Did not receive study treatment	1	0	0	0
Overall Study Concerns about study visit compliance	1	0	0	0

Baseline Characteristics

HIV RNA categories for ART-suppressed participants in Arms A and C only.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A: 1 mg/kg SAR441236 n=4 Participants Participants continued on non-study-provided ART and received 1 mg/kg of SAR441236, administered as a single intravenous (IV) infusion on Day 0 (Cohort 1). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 3 mg/kg for SAR441236 n=4 Participants Experimental: Arm A: 3 mg/kg SAR441236 Participants continued on non-study-provided ART, and received 3 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 2). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 10 mg/kg SAR441236 n=4 Participants Participants continued non-study-provided ART and received 10 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 3). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 30 mg/kg SAR441236 n=10 Participants Participants continued non-study-provided ART and received 30 mg/kg of SAR441236, administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 0 mg/kg SAR441236 n=10 Participants Placebo participants were pooled across those receiving: * 1 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 1). * 3 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 2). * 10 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 3) * 30 mg/kg dose volume-equivalent administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4) All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 1 mg/kg SAR441236 n=5 Participants Participants received 1 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 5). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 30 mg/kg SAR441236 n=2 Participants Participants received 30 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 8). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0.3 mg/kg SAR441236 n=4 Participants Participants continued non-study-provided ART and received 0.3 mg/kg of SAR441236, administered as a subcutaneous (SC) injection(s) on Day 0 (Cohort 10). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 1 mg/kg SAR441236 n=4 Participants Participants continued non-study-provided ART and received 1 mg/kg of SAR441236, administered as an SC injection(s) on Day 0 (Cohort 11). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0 mg/kg SAR441236 n=4 Participants Placebo participants were pooled across those receiving: * 0.3 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 10). * 1 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 11). All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Total n=51 Participants Total of all reporting groups
Age, Continuous	54 years n=4 Participants	47 years n=4 Participants	51 years n=4 Participants	51 years n=10 Participants	57 years n=10 Participants	26 years n=5 Participants	25 years n=2 Participants	54 years n=4 Participants	54 years n=4 Participants	53 years n=4 Participants	53 years n=51 Participants
Sex: Female, Male Female	0 Participants n=4 Participants	2 Participants n=4 Participants	1 Participants n=4 Participants	1 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=5 Participants	0 Participants n=2 Participants	0 Participants n=4 Participants	1 Participants n=4 Participants	0 Participants n=4 Participants	5 Participants n=51 Participants
Sex: Female, Male Male	4 Participants n=4 Participants	2 Participants n=4 Participants	3 Participants n=4 Participants	9 Participants n=10 Participants	10 Participants n=10 Participants	5 Participants n=5 Participants	2 Participants n=2 Participants	4 Participants n=4 Participants	3 Participants n=4 Participants	4 Participants n=4 Participants	46 Participants n=51 Participants
Race/Ethnicity, Customized Race/Ethnicity · White (Non-Hispanic)	3 Participants n=4 Participants	2 Participants n=4 Participants	2 Participants n=4 Participants	3 Participants n=10 Participants	6 Participants n=10 Participants	3 Participants n=5 Participants	0 Participants n=2 Participants	3 Participants n=4 Participants	1 Participants n=4 Participants	1 Participants n=4 Participants	24 Participants n=51 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black (Non-Hispanic)	1 Participants n=4 Participants	2 Participants n=4 Participants	2 Participants n=4 Participants	6 Participants n=10 Participants	1 Participants n=10 Participants	1 Participants n=5 Participants	2 Participants n=2 Participants	1 Participants n=4 Participants	2 Participants n=4 Participants	1 Participants n=4 Participants	19 Participants n=51 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic or Latino (regardless of race)	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	1 Participants n=10 Participants	2 Participants n=10 Participants	1 Participants n=5 Participants	0 Participants n=2 Participants	0 Participants n=4 Participants	1 Participants n=4 Participants	1 Participants n=4 Participants	6 Participants n=51 Participants
Race/Ethnicity, Customized Race/Ethnicity · Other (Non-Hispanic)	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=10 Participants	1 Participants n=10 Participants	0 Participants n=5 Participants	0 Participants n=2 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	1 Participants n=4 Participants	2 Participants n=51 Participants
HIV RNA <40 copies/mL	4 Participants n=4 Participants • HIV RNA categories for ART-suppressed participants in Arms A and C only.	4 Participants n=4 Participants • HIV RNA categories for ART-suppressed participants in Arms A and C only.	4 Participants n=4 Participants • HIV RNA categories for ART-suppressed participants in Arms A and C only.	8 Participants n=10 Participants • HIV RNA categories for ART-suppressed participants in Arms A and C only.	10 Participants n=10 Participants • HIV RNA categories for ART-suppressed participants in Arms A and C only.	—	—	4 Participants n=4 Participants • HIV RNA categories for ART-suppressed participants in Arms A and C only.	4 Participants n=4 Participants • HIV RNA categories for ART-suppressed participants in Arms A and C only.	4 Participants n=4 Participants • HIV RNA categories for ART-suppressed participants in Arms A and C only.	42 Participants n=44 Participants • HIV RNA categories for ART-suppressed participants in Arms A and C only.
HIV RNA ≥40 copies/mL	0 Participants n=4 Participants • HIV RNA categories for ART-suppressed participants in Arms A and C only.	0 Participants n=4 Participants • HIV RNA categories for ART-suppressed participants in Arms A and C only.	0 Participants n=4 Participants • HIV RNA categories for ART-suppressed participants in Arms A and C only.	2 Participants n=10 Participants • HIV RNA categories for ART-suppressed participants in Arms A and C only.	0 Participants n=10 Participants • HIV RNA categories for ART-suppressed participants in Arms A and C only.	—	—	0 Participants n=4 Participants • HIV RNA categories for ART-suppressed participants in Arms A and C only.	0 Participants n=4 Participants • HIV RNA categories for ART-suppressed participants in Arms A and C only.	0 Participants n=4 Participants • HIV RNA categories for ART-suppressed participants in Arms A and C only.	2 Participants n=44 Participants • HIV RNA categories for ART-suppressed participants in Arms A and C only.
HIV RNA 10,000-29,000 copies/mL	—	—	—	—	—	1 Participants n=5 Participants • HIV RNA categories for viremic participants in Arm B only.	0 Participants n=2 Participants • HIV RNA categories for viremic participants in Arm B only.	—	—	—	1 Participants n=7 Participants • HIV RNA categories for viremic participants in Arm B only.
HIV RNA 30,000-99,999 copies/mL	—	—	—	—	—	3 Participants n=5 Participants • HIV RNA categories for viremic participants in Arm B only.	1 Participants n=2 Participants • HIV RNA categories for viremic participants in Arm B only.	—	—	—	4 Participants n=7 Participants • HIV RNA categories for viremic participants in Arm B only.
HIV RNA 100,000-200,000 copies/mL	—	—	—	—	—	0 Participants n=5 Participants • HIV RNA categories for viremic participants in Arm B only.	1 Participants n=2 Participants • HIV RNA categories for viremic participants in Arm B only.	—	—	—	1 Participants n=7 Participants • HIV RNA categories for viremic participants in Arm B only.
HIV RNA ≥200,000 copies/mL	—	—	—	—	—	1 Participants n=5 Participants • HIV RNA categories for viremic participants in Arm B only.	0 Participants n=2 Participants • HIV RNA categories for viremic participants in Arm B only.	—	—	—	1 Participants n=7 Participants • HIV RNA categories for viremic participants in Arm B only.
CD4 Cell Count 250-499 cells/mm^3	0 Participants n=4 Participants	2 Participants n=4 Participants	0 Participants n=4 Participants	3 Participants n=10 Participants	3 Participants n=10 Participants	2 Participants n=5 Participants	2 Participants n=2 Participants	1 Participants n=4 Participants	0 Participants n=4 Participants	1 Participants n=4 Participants	14 Participants n=51 Participants
CD4 Cell Count ≥500 cells/mm^3	4 Participants n=4 Participants	2 Participants n=4 Participants	4 Participants n=4 Participants	7 Participants n=10 Participants	7 Participants n=10 Participants	3 Participants n=5 Participants	0 Participants n=2 Participants	3 Participants n=4 Participants	4 Participants n=4 Participants	3 Participants n=4 Participants	37 Participants n=51 Participants
Baseline Weight	91 kilograms n=4 Participants	83 kilograms n=4 Participants	96 kilograms n=4 Participants	83 kilograms n=10 Participants	88 kilograms n=10 Participants	67 kilograms n=5 Participants	83 kilograms n=2 Participants	86 kilograms n=4 Participants	97 kilograms n=4 Participants	82 kilograms n=4 Participants	87 kilograms n=51 Participants

PRIMARY outcome

Timeframe: Measured from Day 0 through entire study follow-up, up to 24 weeks post study treatment administration for single dose cohorts (all arms) and up to 36 weeks after the fourth study treatment administration for the multi-dose cohort (Arm A only).

Population: All participants exposed to SAR441236/placebo. Those receiving placebo of any dose-volume equivalent are pooled w/in arm per the analysis plan. The highest dose in ArmA (Cohort 4) was designed to with dual safety objectives: 1) evaluate the safety of a single dose for 12 weeks and 2) evaluate the safety of multiple doses if the initial dose proved safe.

Outcome measures

Outcome measures
Measure	Arm A: 1 mg/kg SAR441236 n=4 Participants Participants continued on non-study-provided ART and received 1 mg/kg of SAR441236, administered as a single intravenous (IV) infusion on Day 0 (Cohort 1). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 3 mg/kg for SAR441236 n=4 Participants Experimental: Arm A: 3 mg/kg SAR441236 Participants continued on non-study-provided ART, and received 3 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 2). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 10 mg/kg SAR441236 n=4 Participants Participants continued non-study-provided ART and received 10 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 3). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 30 mg/kg SAR441236 n=10 Participants Participants continued non-study-provided ART and received 30 mg/kg of SAR441236, administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 0 mg/kg SAR441236 n=10 Participants Placebo participants were pooled across those receiving: * 1 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 1). * 3 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 2). * 10 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 3) * 30 mg/kg dose volume-equivalent administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4) All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 1 mg/kg SAR441236 n=5 Participants Participants received 1 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 5). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 30 mg/kg SAR441236 n=2 Participants Participants received 30 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 8). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0.3 mg/kg SAR441236 n=4 Participants Participants continued non-study-provided ART and received 0.3 mg/kg of SAR441236, administered as a subcutaneous (SC) injection(s) on Day 0 (Cohort 10). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 1 mg/kg SAR441236 n=4 Participants Participants continued non-study-provided ART and received 1 mg/kg of SAR441236, administered as an SC injection(s) on Day 0 (Cohort 11). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0 mg/kg SAR441236 n=4 Participants Placebo participants were pooled across those receiving: * 0.3 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 10). * 1 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 11). All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)
Proportion of Participants Experiencing a Grade 3 or Higher Adverse Event (AE) That is Related to Study Treatment.	0 Proportion of participants Interval 0.0 to 0.6	0 Proportion of participants Interval 0.0 to 0.6	0 Proportion of participants Interval 0.0 to 0.6	0 Proportion of participants Interval 0.0 to 0.31	0 Proportion of participants Interval 0.0 to 0.31	0 Proportion of participants Interval 0.0 to 0.52	0 Proportion of participants Interval 0.0 to 0.84	0 Proportion of participants Interval 0.0 to 0.6	0 Proportion of participants Interval 0.0 to 0.6	0 Proportion of participants Interval 0.0 to 0.6

PRIMARY outcome

Timeframe: SAR441236 PK samples at pre-dose, Hours 0, 2 (Arm A, B only) , 4 (Arm A, B only), 6 (Arm A, B only), and 10, Days 1, 2, 3, 4 (Arm B only), 7, 10 (Arm B only), and Weeks 2, 4, 8 (single dose only), 10 (multi dose only), and 12.

Population: All participants who have been exposed to SAR441236 and have evaluable levels of SAR441236 such that AUC 0-12WK can be calculated.

Dose-normalized Area Under the Concentration time curve (AUC) for each participant was calculated from all available SAR441236 concentrations measured prior to and after first treatment and prior to any subsequent treatment instances (Arm A: 30 mg/kg only). Standard noncompartmental techniques, using Phoenix WinNonlin, were used to determine AUC 0-12WK.

Outcome measures

Outcome measures
Measure	Arm A: 1 mg/kg SAR441236 n=4 Participants Participants continued on non-study-provided ART and received 1 mg/kg of SAR441236, administered as a single intravenous (IV) infusion on Day 0 (Cohort 1). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 3 mg/kg for SAR441236 n=4 Participants Experimental: Arm A: 3 mg/kg SAR441236 Participants continued on non-study-provided ART, and received 3 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 2). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 10 mg/kg SAR441236 n=4 Participants Participants continued non-study-provided ART and received 10 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 3). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 30 mg/kg SAR441236 n=7 Participants Participants continued non-study-provided ART and received 30 mg/kg of SAR441236, administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 0 mg/kg SAR441236 n=1 Participants Placebo participants were pooled across those receiving: * 1 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 1). * 3 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 2). * 10 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 3) * 30 mg/kg dose volume-equivalent administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4) All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 1 mg/kg SAR441236 n=1 Participants Participants received 1 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 5). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 30 mg/kg SAR441236 n=4 Participants Participants received 30 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 8). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0.3 mg/kg SAR441236 n=4 Participants Participants continued non-study-provided ART and received 0.3 mg/kg of SAR441236, administered as a subcutaneous (SC) injection(s) on Day 0 (Cohort 10). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 1 mg/kg SAR441236 Participants continued non-study-provided ART and received 1 mg/kg of SAR441236, administered as an SC injection(s) on Day 0 (Cohort 11). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0 mg/kg SAR441236 Placebo participants were pooled across those receiving: * 0.3 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 10). * 1 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 11). All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)
Mean Dose-normalized AUC 0-12wk of SAR441236	593 (ug*day/mL)/(mg/kg) Standard Error 282	631 (ug*day/mL)/(mg/kg) Standard Error 120	610 (ug*day/mL)/(mg/kg) Standard Error 54.5	743 (ug*day/mL)/(mg/kg) Standard Error 296	552 (ug*day/mL)/(mg/kg)	159 (ug*day/mL)/(mg/kg)	254 (ug*day/mL)/(mg/kg) Standard Error 145	236 (ug*day/mL)/(mg/kg) Standard Error 126	—	—

PRIMARY outcome

Timeframe: Measured at Day 0 and Day 7

Population: Arm B participants who actually received ≥0.9 mg/kg SAR441236, had an entry plasma HIV-1 RNA ≥ 5000 copies/mL, and had Plasma HIV-1 RNA measured at the scheduled study visits were included.

Baseline was defined as the last measurement taken prior to treatment initiation. Change was calculated as the log10-transformed value on Day 7 minus the log10-transformed value at baseline.

Outcome measures

Outcome measures
Measure	Arm A: 1 mg/kg SAR441236 n=5 Participants Participants continued on non-study-provided ART and received 1 mg/kg of SAR441236, administered as a single intravenous (IV) infusion on Day 0 (Cohort 1). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 3 mg/kg for SAR441236 n=2 Participants Experimental: Arm A: 3 mg/kg SAR441236 Participants continued on non-study-provided ART, and received 3 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 2). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 10 mg/kg SAR441236 Participants continued non-study-provided ART and received 10 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 3). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 30 mg/kg SAR441236 Participants continued non-study-provided ART and received 30 mg/kg of SAR441236, administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 0 mg/kg SAR441236 Placebo participants were pooled across those receiving: * 1 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 1). * 3 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 2). * 10 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 3) * 30 mg/kg dose volume-equivalent administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4) All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 1 mg/kg SAR441236 Participants received 1 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 5). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 30 mg/kg SAR441236 Participants received 30 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 8). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0.3 mg/kg SAR441236 Participants continued non-study-provided ART and received 0.3 mg/kg of SAR441236, administered as a subcutaneous (SC) injection(s) on Day 0 (Cohort 10). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 1 mg/kg SAR441236 Participants continued non-study-provided ART and received 1 mg/kg of SAR441236, administered as an SC injection(s) on Day 0 (Cohort 11). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0 mg/kg SAR441236 Placebo participants were pooled across those receiving: * 0.3 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 10). * 1 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 11). All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)
Mean Change in Plasma HIV-1 RNA (log10 Copies/mL) From Baseline to Day 7 of SAR441236 Monotherapy for Viremic Participants With HIV (Arm B Cohorts)	-0.10 log10 copies/mL Standard Deviation 0.42	-0.38 log10 copies/mL Standard Deviation 0.24	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Measured at Day 0 and at Day 1, 2, 3, and 4, and Week 1, 2, and 3

Baseline was defined as the last measurement taken prior to treatment initiation. Change was calculated as the log10-transformed value of plasma HIV-1 RNA at the post-infusion time point minus the log10-transformed value at baseline.

Outcome measures

Outcome measures
Measure	Arm A: 1 mg/kg SAR441236 n=5 Participants Participants continued on non-study-provided ART and received 1 mg/kg of SAR441236, administered as a single intravenous (IV) infusion on Day 0 (Cohort 1). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 3 mg/kg for SAR441236 n=2 Participants Experimental: Arm A: 3 mg/kg SAR441236 Participants continued on non-study-provided ART, and received 3 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 2). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 10 mg/kg SAR441236 Participants continued non-study-provided ART and received 10 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 3). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 30 mg/kg SAR441236 Participants continued non-study-provided ART and received 30 mg/kg of SAR441236, administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 0 mg/kg SAR441236 Placebo participants were pooled across those receiving: * 1 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 1). * 3 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 2). * 10 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 3) * 30 mg/kg dose volume-equivalent administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4) All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 1 mg/kg SAR441236 Participants received 1 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 5). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 30 mg/kg SAR441236 Participants received 30 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 8). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0.3 mg/kg SAR441236 Participants continued non-study-provided ART and received 0.3 mg/kg of SAR441236, administered as a subcutaneous (SC) injection(s) on Day 0 (Cohort 10). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 1 mg/kg SAR441236 Participants continued non-study-provided ART and received 1 mg/kg of SAR441236, administered as an SC injection(s) on Day 0 (Cohort 11). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0 mg/kg SAR441236 Placebo participants were pooled across those receiving: * 0.3 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 10). * 1 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 11). All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)
Mean Change in Plasma HIV-1 RNA (log10 Copies/mL) From Baseline to Post-infusion Time Points During SAR441236 Monotherapy for Viremic Participants With HIV (Arm B Cohorts) Change from baseline to Day 1	0.04 log10 copies/mL Standard Deviation 0.07	0.10 log10 copies/mL Standard Deviation 0.12	—	—	—	—	—	—	—	—
Mean Change in Plasma HIV-1 RNA (log10 Copies/mL) From Baseline to Post-infusion Time Points During SAR441236 Monotherapy for Viremic Participants With HIV (Arm B Cohorts) Change from baseline to Day 2	0.04 log10 copies/mL Standard Deviation 0.14	-0.06 log10 copies/mL Standard Deviation 0.07	—	—	—	—	—	—	—	—
Mean Change in Plasma HIV-1 RNA (log10 Copies/mL) From Baseline to Post-infusion Time Points During SAR441236 Monotherapy for Viremic Participants With HIV (Arm B Cohorts) Change from baseline to Day 3	-0.04 log10 copies/mL Standard Deviation 0.20	-0.39 log10 copies/mL Standard Deviation 0.04	—	—	—	—	—	—	—	—
Mean Change in Plasma HIV-1 RNA (log10 Copies/mL) From Baseline to Post-infusion Time Points During SAR441236 Monotherapy for Viremic Participants With HIV (Arm B Cohorts) Change from baseline to Day 4	0.01 log10 copies/mL Standard Deviation 0.40	-0.68 log10 copies/mL Standard Deviation 0.03	—	—	—	—	—	—	—	—
Mean Change in Plasma HIV-1 RNA (log10 Copies/mL) From Baseline to Post-infusion Time Points During SAR441236 Monotherapy for Viremic Participants With HIV (Arm B Cohorts) Change from baseline to Week 1	-0.10 log10 copies/mL Standard Deviation 0.42	-0.38 log10 copies/mL Standard Deviation 0.24	—	—	—	—	—	—	—	—
Mean Change in Plasma HIV-1 RNA (log10 Copies/mL) From Baseline to Post-infusion Time Points During SAR441236 Monotherapy for Viremic Participants With HIV (Arm B Cohorts) Change from baseline to Week 2	-0.08 log10 copies/mL Standard Deviation 0.08	0.09 log10 copies/mL Standard Deviation 0.38	—	—	—	—	—	—	—	—
Mean Change in Plasma HIV-1 RNA (log10 Copies/mL) From Baseline to Post-infusion Time Points During SAR441236 Monotherapy for Viremic Participants With HIV (Arm B Cohorts) Change from baseline to Week 3	0.03 log10 copies/mL Standard Deviation 0.37	0.07 log10 copies/mL Standard Deviation 0.48	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Measured at Day 0 and Day 14

Baseline was defined as the last measurement taken prior to treatment initiation. Change was calculated as the value of plasma HIV-1 RNA on Day 14 minus the value at baseline.

Outcome measures

Outcome measures
Measure	Arm A: 1 mg/kg SAR441236 n=4 Participants Participants continued on non-study-provided ART and received 1 mg/kg of SAR441236, administered as a single intravenous (IV) infusion on Day 0 (Cohort 1). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 3 mg/kg for SAR441236 n=2 Participants Experimental: Arm A: 3 mg/kg SAR441236 Participants continued on non-study-provided ART, and received 3 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 2). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 10 mg/kg SAR441236 Participants continued non-study-provided ART and received 10 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 3). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 30 mg/kg SAR441236 Participants continued non-study-provided ART and received 30 mg/kg of SAR441236, administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 0 mg/kg SAR441236 Placebo participants were pooled across those receiving: * 1 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 1). * 3 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 2). * 10 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 3) * 30 mg/kg dose volume-equivalent administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4) All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 1 mg/kg SAR441236 Participants received 1 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 5). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 30 mg/kg SAR441236 Participants received 30 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 8). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0.3 mg/kg SAR441236 Participants continued non-study-provided ART and received 0.3 mg/kg of SAR441236, administered as a subcutaneous (SC) injection(s) on Day 0 (Cohort 10). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 1 mg/kg SAR441236 Participants continued non-study-provided ART and received 1 mg/kg of SAR441236, administered as an SC injection(s) on Day 0 (Cohort 11). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0 mg/kg SAR441236 Placebo participants were pooled across those receiving: * 0.3 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 10). * 1 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 11). All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)
Mean Change in Plasma HIV-1 RNA (log10 Copies/mL) From Baseline to Day 14 of SAR441236 Monotherapy for Viremic Participants With HIV (Arm B Cohorts)	-0.08 log10 copies/mL Standard Deviation 0.08	0.09 log10 copies/mL Standard Deviation 0.38	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Measured at Day 0 and at up to Day 28 (while on SAR441236 monotherapy)

Population: Arm B participants who actually received ≥0.9 mg/kg SAR441236 and had an entry plasma HIV-1 RNA ≥ 5000 copies/mL.

The maximum reduction in plasma HIV-1 RNA was calculated as the largest decline from baseline, defined as the last measurement taken prior to treatment initiation, to any post-infusion timepoint while the participant was on SAR441236 monotherapy (i.e., prior to initiating or reinitiating ART).

Outcome measures

Outcome measures
Measure	Arm A: 1 mg/kg SAR441236 n=5 Participants Participants continued on non-study-provided ART and received 1 mg/kg of SAR441236, administered as a single intravenous (IV) infusion on Day 0 (Cohort 1). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 3 mg/kg for SAR441236 n=2 Participants Experimental: Arm A: 3 mg/kg SAR441236 Participants continued on non-study-provided ART, and received 3 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 2). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 10 mg/kg SAR441236 Participants continued non-study-provided ART and received 10 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 3). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 30 mg/kg SAR441236 Participants continued non-study-provided ART and received 30 mg/kg of SAR441236, administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 0 mg/kg SAR441236 Placebo participants were pooled across those receiving: * 1 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 1). * 3 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 2). * 10 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 3) * 30 mg/kg dose volume-equivalent administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4) All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 1 mg/kg SAR441236 Participants received 1 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 5). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 30 mg/kg SAR441236 Participants received 30 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 8). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0.3 mg/kg SAR441236 Participants continued non-study-provided ART and received 0.3 mg/kg of SAR441236, administered as a subcutaneous (SC) injection(s) on Day 0 (Cohort 10). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 1 mg/kg SAR441236 Participants continued non-study-provided ART and received 1 mg/kg of SAR441236, administered as an SC injection(s) on Day 0 (Cohort 11). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0 mg/kg SAR441236 Placebo participants were pooled across those receiving: * 0.3 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 10). * 1 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 11). All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)
Mean Maximum Reduction of Plasma HIV-1 RNA During up to 28 Days of SAR441236 Monotherapy for Viremic Participants With HIV (Arm B Cohorts)	-0.30 log10 copies/mL Standard Deviation 0.23	-0.68 log10 copies/mL Standard Deviation 0.03	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Measured at Day 0 and at Week 2, 4, 12, and 24

Population: Participants who received SAR441236 (not placebo) were tested for the presence of anti-drug antibodies. Only participants enrolled in single-dose cohorts were included.

Number of participants who were anti-drug antibody (ADA) negative, ADA positive (treatment induced), and missing were calculated at each sampled timepoint.

Outcome measures

Outcome measures
Measure	Arm A: 1 mg/kg SAR441236 n=4 Participants Participants continued on non-study-provided ART and received 1 mg/kg of SAR441236, administered as a single intravenous (IV) infusion on Day 0 (Cohort 1). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 3 mg/kg for SAR441236 n=4 Participants Experimental: Arm A: 3 mg/kg SAR441236 Participants continued on non-study-provided ART, and received 3 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 2). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 10 mg/kg SAR441236 n=4 Participants Participants continued non-study-provided ART and received 10 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 3). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 30 mg/kg SAR441236 n=5 Participants Participants continued non-study-provided ART and received 30 mg/kg of SAR441236, administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 0 mg/kg SAR441236 n=2 Participants Placebo participants were pooled across those receiving: * 1 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 1). * 3 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 2). * 10 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 3) * 30 mg/kg dose volume-equivalent administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4) All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 1 mg/kg SAR441236 n=4 Participants Participants received 1 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 5). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 30 mg/kg SAR441236 n=4 Participants Participants received 30 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 8). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0.3 mg/kg SAR441236 Participants continued non-study-provided ART and received 0.3 mg/kg of SAR441236, administered as a subcutaneous (SC) injection(s) on Day 0 (Cohort 10). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 1 mg/kg SAR441236 Participants continued non-study-provided ART and received 1 mg/kg of SAR441236, administered as an SC injection(s) on Day 0 (Cohort 11). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0 mg/kg SAR441236 Placebo participants were pooled across those receiving: * 0.3 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 10). * 1 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 11). All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)
Attributions of Anti-SAR441236 Antibodies Among Participants in Single-dose Cohorts. ADA Status at Week 4 · Negative	3 Participants	4 Participants	3 Participants	1 Participants	2 Participants	4 Participants	4 Participants	—	—	—
Attributions of Anti-SAR441236 Antibodies Among Participants in Single-dose Cohorts. ADA Status at Week 4 · Missing	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Attributions of Anti-SAR441236 Antibodies Among Participants in Single-dose Cohorts. ADA Status at Week 12 · Positive: Treatment-Induced	0 Participants	1 Participants	1 Participants	2 Participants	0 Participants	0 Participants	1 Participants	—	—	—
Attributions of Anti-SAR441236 Antibodies Among Participants in Single-dose Cohorts. ADA Status at Week 12 · Negative	4 Participants	3 Participants	3 Participants	0 Participants	1 Participants	4 Participants	3 Participants	—	—	—
Attributions of Anti-SAR441236 Antibodies Among Participants in Single-dose Cohorts. ADA Status at Week 12 · Missing	0 Participants	0 Participants	0 Participants	3 Participants	1 Participants	0 Participants	0 Participants	—	—	—
Attributions of Anti-SAR441236 Antibodies Among Participants in Single-dose Cohorts. ADA Status at Week 24 · Positive: Treatment-Induced	0 Participants	1 Participants	0 Participants	3 Participants	0 Participants	0 Participants	2 Participants	—	—	—
Attributions of Anti-SAR441236 Antibodies Among Participants in Single-dose Cohorts. ADA Status at Week 24 · Negative	4 Participants	3 Participants	4 Participants	0 Participants	0 Participants	4 Participants	2 Participants	—	—	—
Attributions of Anti-SAR441236 Antibodies Among Participants in Single-dose Cohorts. ADA Status at Week 24 · Missing	0 Participants	0 Participants	0 Participants	2 Participants	2 Participants	0 Participants	0 Participants	—	—	—
Attributions of Anti-SAR441236 Antibodies Among Participants in Single-dose Cohorts. ADA Status at Day 0 · Positive: Treatment-Induced	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Attributions of Anti-SAR441236 Antibodies Among Participants in Single-dose Cohorts. ADA Status at Day 0 · Negative	4 Participants	4 Participants	4 Participants	5 Participants	2 Participants	4 Participants	4 Participants	—	—	—
Attributions of Anti-SAR441236 Antibodies Among Participants in Single-dose Cohorts. ADA Status at Day 0 · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Attributions of Anti-SAR441236 Antibodies Among Participants in Single-dose Cohorts. ADA Status at Week 2 · Positive: Treatment-Induced	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants	1 Participants	—	—	—
Attributions of Anti-SAR441236 Antibodies Among Participants in Single-dose Cohorts. ADA Status at Week 2 · Negative	4 Participants	4 Participants	3 Participants	3 Participants	1 Participants	4 Participants	3 Participants	—	—	—
Attributions of Anti-SAR441236 Antibodies Among Participants in Single-dose Cohorts. ADA Status at Week 2 · Missing	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Attributions of Anti-SAR441236 Antibodies Among Participants in Single-dose Cohorts. ADA Status at Week 4 · Positive: Treatment-Induced	0 Participants	0 Participants	1 Participants	4 Participants	0 Participants	0 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: Measured at Day 0, at Weeks 2 and 4 after Infusion 1, at Infusion 2, at Infusion 3, at Infusion 4, and at Weeks 12 and 36 post-Infusion 4

Population: Participants who received SAR441236 (not placebo) were tested for the presence of anti-drug antibodies. Only participants enrolled in the multi-dose cohort were included. Samples for one 30 mg/kg SAR441236 were lost in a freezer malfunction and no results were able to be obtained.

Number of participants who were anti-drug antibody (ADA) negative, ADA positive (treatment induced), and missing were calculated at each sampled timepoint.

Outcome measures

Outcome measures
Measure	Arm A: 1 mg/kg SAR441236 n=9 Participants Participants continued on non-study-provided ART and received 1 mg/kg of SAR441236, administered as a single intravenous (IV) infusion on Day 0 (Cohort 1). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 3 mg/kg for SAR441236 Experimental: Arm A: 3 mg/kg SAR441236 Participants continued on non-study-provided ART, and received 3 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 2). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 10 mg/kg SAR441236 Participants continued non-study-provided ART and received 10 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 3). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 30 mg/kg SAR441236 Participants continued non-study-provided ART and received 30 mg/kg of SAR441236, administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 0 mg/kg SAR441236 Placebo participants were pooled across those receiving: * 1 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 1). * 3 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 2). * 10 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 3) * 30 mg/kg dose volume-equivalent administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4) All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 1 mg/kg SAR441236 Participants received 1 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 5). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 30 mg/kg SAR441236 Participants received 30 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 8). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0.3 mg/kg SAR441236 Participants continued non-study-provided ART and received 0.3 mg/kg of SAR441236, administered as a subcutaneous (SC) injection(s) on Day 0 (Cohort 10). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 1 mg/kg SAR441236 Participants continued non-study-provided ART and received 1 mg/kg of SAR441236, administered as an SC injection(s) on Day 0 (Cohort 11). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0 mg/kg SAR441236 Placebo participants were pooled across those receiving: * 0.3 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 10). * 1 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 11). All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)
Attributions of Anti-SAR441236 Antibodies Among Participants in Multi-dose Cohort. ADA Status at Inf 1: Day 0 · Positive: Treatment-Induced	0 Participants	—	—	—	—	—	—	—	—	—
Attributions of Anti-SAR441236 Antibodies Among Participants in Multi-dose Cohort. ADA Status at Inf 1: Day 0 · Negative	9 Participants	—	—	—	—	—	—	—	—	—
Attributions of Anti-SAR441236 Antibodies Among Participants in Multi-dose Cohort. ADA Status at Inf 1: Day 0 · Missing	0 Participants	—	—	—	—	—	—	—	—	—
Attributions of Anti-SAR441236 Antibodies Among Participants in Multi-dose Cohort. ADA Status at Inf 1: Week 2 · Positive: Treatment-Induced	0 Participants	—	—	—	—	—	—	—	—	—
Attributions of Anti-SAR441236 Antibodies Among Participants in Multi-dose Cohort. ADA Status at Inf 1: Week 2 · Negative	8 Participants	—	—	—	—	—	—	—	—	—
Attributions of Anti-SAR441236 Antibodies Among Participants in Multi-dose Cohort. ADA Status at Inf 1: Week 2 · Missing	1 Participants	—	—	—	—	—	—	—	—	—
Attributions of Anti-SAR441236 Antibodies Among Participants in Multi-dose Cohort. ADA Status at Inf 1: Week 4 · Positive: Treatment-Induced	0 Participants	—	—	—	—	—	—	—	—	—
Attributions of Anti-SAR441236 Antibodies Among Participants in Multi-dose Cohort. ADA Status at Inf 1: Week 4 · Negative	7 Participants	—	—	—	—	—	—	—	—	—
Attributions of Anti-SAR441236 Antibodies Among Participants in Multi-dose Cohort. ADA Status at Inf 1: Week 4 · Missing	2 Participants	—	—	—	—	—	—	—	—	—
Attributions of Anti-SAR441236 Antibodies Among Participants in Multi-dose Cohort. ADA Status at Inf 2: Day 0 · Positive: Treatment-Induced	1 Participants	—	—	—	—	—	—	—	—	—
Attributions of Anti-SAR441236 Antibodies Among Participants in Multi-dose Cohort. ADA Status at Inf 2: Day 0 · Negative	5 Participants	—	—	—	—	—	—	—	—	—
Attributions of Anti-SAR441236 Antibodies Among Participants in Multi-dose Cohort. ADA Status at Inf 2: Day 0 · Missing	3 Participants	—	—	—	—	—	—	—	—	—
Attributions of Anti-SAR441236 Antibodies Among Participants in Multi-dose Cohort. ADA Status at Inf 3: Day 0 · Positive: Treatment-Induced	0 Participants	—	—	—	—	—	—	—	—	—
Attributions of Anti-SAR441236 Antibodies Among Participants in Multi-dose Cohort. ADA Status at Inf 3: Day 0 · Negative	6 Participants	—	—	—	—	—	—	—	—	—
Attributions of Anti-SAR441236 Antibodies Among Participants in Multi-dose Cohort. ADA Status at Inf 3: Day 0 · Missing	3 Participants	—	—	—	—	—	—	—	—	—
Attributions of Anti-SAR441236 Antibodies Among Participants in Multi-dose Cohort. ADA Status at Inf 4: Day 0 · Positive: Treatment-Induced	0 Participants	—	—	—	—	—	—	—	—	—
Attributions of Anti-SAR441236 Antibodies Among Participants in Multi-dose Cohort. ADA Status at Inf 4: Day 0 · Negative	6 Participants	—	—	—	—	—	—	—	—	—
Attributions of Anti-SAR441236 Antibodies Among Participants in Multi-dose Cohort. ADA Status at Inf 4: Day 0 · Missing	3 Participants	—	—	—	—	—	—	—	—	—
Attributions of Anti-SAR441236 Antibodies Among Participants in Multi-dose Cohort. ADA Status at Inf 4: Week 12 · Positive: Treatment-Induced	0 Participants	—	—	—	—	—	—	—	—	—
Attributions of Anti-SAR441236 Antibodies Among Participants in Multi-dose Cohort. ADA Status at Inf 4: Week 12 · Negative	6 Participants	—	—	—	—	—	—	—	—	—
Attributions of Anti-SAR441236 Antibodies Among Participants in Multi-dose Cohort. ADA Status at Inf 4: Week 12 · Missing	3 Participants	—	—	—	—	—	—	—	—	—
Attributions of Anti-SAR441236 Antibodies Among Participants in Multi-dose Cohort. ADA Status at Inf 4: Week 36 · Positive: Treatment-Induced	1 Participants	—	—	—	—	—	—	—	—	—
Attributions of Anti-SAR441236 Antibodies Among Participants in Multi-dose Cohort. ADA Status at Inf 4: Week 36 · Negative	4 Participants	—	—	—	—	—	—	—	—	—
Attributions of Anti-SAR441236 Antibodies Among Participants in Multi-dose Cohort. ADA Status at Inf 4: Week 36 · Missing	4 Participants	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Measured at Day 0 and Week 12

Population: All participants who received study treatment (SAR441236 or placebo) and had CD4 counts measured at the scheduled study visits were included.

Baseline was defined as the last measurement obtained prior to treatment initiation. Change was calculated as the value of CD4+ T cell counts (cells/mm\^3) at Week 12 (prior to subsequent study treatment, if any) minus the value at baseline.

Outcome measures

Outcome measures
Measure	Arm A: 1 mg/kg SAR441236 n=4 Participants Participants continued on non-study-provided ART and received 1 mg/kg of SAR441236, administered as a single intravenous (IV) infusion on Day 0 (Cohort 1). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 3 mg/kg for SAR441236 n=4 Participants Experimental: Arm A: 3 mg/kg SAR441236 Participants continued on non-study-provided ART, and received 3 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 2). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 10 mg/kg SAR441236 n=3 Participants Participants continued non-study-provided ART and received 10 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 3). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 30 mg/kg SAR441236 n=9 Participants Participants continued non-study-provided ART and received 30 mg/kg of SAR441236, administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 0 mg/kg SAR441236 n=10 Participants Placebo participants were pooled across those receiving: * 1 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 1). * 3 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 2). * 10 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 3) * 30 mg/kg dose volume-equivalent administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4) All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 1 mg/kg SAR441236 n=2 Participants Participants received 1 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 5). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 30 mg/kg SAR441236 n=1 Participants Participants received 30 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 8). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0.3 mg/kg SAR441236 n=4 Participants Participants continued non-study-provided ART and received 0.3 mg/kg of SAR441236, administered as a subcutaneous (SC) injection(s) on Day 0 (Cohort 10). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 1 mg/kg SAR441236 n=4 Participants Participants continued non-study-provided ART and received 1 mg/kg of SAR441236, administered as an SC injection(s) on Day 0 (Cohort 11). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0 mg/kg SAR441236 n=4 Participants Placebo participants were pooled across those receiving: * 0.3 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 10). * 1 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 11). All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)
Mean Change From Baseline in CD4+ T Cell Counts Following the First Treatment of SAR441236 or Placebo for All Cohorts	-6 cells/mm^3 Standard Deviation 87	-96 cells/mm^3 Standard Deviation 222	96 cells/mm^3 Standard Deviation 249	-36 cells/mm^3 Standard Deviation 246	-43 cells/mm^3 Standard Deviation 117	10 cells/mm^3 Standard Deviation 273	138 cells/mm^3 Standard Deviation NA No standard deviation due to N=1	61 cells/mm^3 Standard Deviation 176	-136 cells/mm^3 Standard Deviation 216	-53 cells/mm^3 Standard Deviation 289

SECONDARY outcome

Timeframe: Measured at Day 0 and at Week 12 after each infusion

Population: Arm A participants who received multiple infusions (SAR441236 or placebo) and had CD4 count measured at the scheduled study visits were included.

Baseline was defined as the last measurement obtained prior to treatment initiation. Change was calculated as the value of CD4 + T cell counts (cells/mm\^3) at Week 12 after each infusion minus the value at baseline.

Outcome measures

Outcome measures
Measure	Arm A: 1 mg/kg SAR441236 n=6 Participants Participants continued on non-study-provided ART and received 1 mg/kg of SAR441236, administered as a single intravenous (IV) infusion on Day 0 (Cohort 1). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 3 mg/kg for SAR441236 n=4 Participants Experimental: Arm A: 3 mg/kg SAR441236 Participants continued on non-study-provided ART, and received 3 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 2). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 10 mg/kg SAR441236 Participants continued non-study-provided ART and received 10 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 3). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 30 mg/kg SAR441236 Participants continued non-study-provided ART and received 30 mg/kg of SAR441236, administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 0 mg/kg SAR441236 Placebo participants were pooled across those receiving: * 1 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 1). * 3 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 2). * 10 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 3) * 30 mg/kg dose volume-equivalent administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4) All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 1 mg/kg SAR441236 Participants received 1 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 5). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 30 mg/kg SAR441236 Participants received 30 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 8). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0.3 mg/kg SAR441236 Participants continued non-study-provided ART and received 0.3 mg/kg of SAR441236, administered as a subcutaneous (SC) injection(s) on Day 0 (Cohort 10). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 1 mg/kg SAR441236 Participants continued non-study-provided ART and received 1 mg/kg of SAR441236, administered as an SC injection(s) on Day 0 (Cohort 11). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0 mg/kg SAR441236 Placebo participants were pooled across those receiving: * 0.3 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 10). * 1 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 11). All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)
Mean Change From Baseline in CD4+ T Cell Counts Following Each Infusion for Cohort 4 Change in from baseline to Week 12 after 2nd treatment	73 cells/mm^3 Standard Deviation 357	28 cells/mm^3 Standard Deviation 190	—	—	—	—	—	—	—	—
Mean Change From Baseline in CD4+ T Cell Counts Following Each Infusion for Cohort 4 Change in from baseline to Week 12 after 3rd treatment	78 cells/mm^3 Standard Deviation 232	17 cells/mm^3 Standard Deviation 252	—	—	—	—	—	—	—	—
Mean Change From Baseline in CD4+ T Cell Counts Following Each Infusion for Cohort 4 Change in from baseline to Week 12 after 4th treatment	-83 cells/mm^3 Standard Deviation 253	77 cells/mm^3 Standard Deviation 111	—	—	—	—	—	—	—	—

SECONDARY outcome

Population: All participants exposed to SAR441236 with evaluable levels of SAR441236 such that Cmax can be derived.

Cmax for each participant was calculated as the maximum observed concentration from all available SAR441236 concentrations measured prior to and after first treatment and prior to any subsequent treatment instances (Arm A: 30 mg/kg only). Standard noncompartmental techniques, using Phoenix WinNonlin, were used to determine Cmax.

Outcome measures

Outcome measures
Measure	Arm A: 1 mg/kg SAR441236 n=4 Participants Participants continued on non-study-provided ART and received 1 mg/kg of SAR441236, administered as a single intravenous (IV) infusion on Day 0 (Cohort 1). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 3 mg/kg for SAR441236 n=4 Participants Experimental: Arm A: 3 mg/kg SAR441236 Participants continued on non-study-provided ART, and received 3 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 2). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 10 mg/kg SAR441236 n=4 Participants Participants continued non-study-provided ART and received 10 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 3). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 30 mg/kg SAR441236 n=9 Participants Participants continued non-study-provided ART and received 30 mg/kg of SAR441236, administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 0 mg/kg SAR441236 n=5 Participants Placebo participants were pooled across those receiving: * 1 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 1). * 3 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 2). * 10 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 3) * 30 mg/kg dose volume-equivalent administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4) All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 1 mg/kg SAR441236 n=2 Participants Participants received 1 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 5). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 30 mg/kg SAR441236 n=4 Participants Participants received 30 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 8). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0.3 mg/kg SAR441236 n=4 Participants Participants continued non-study-provided ART and received 0.3 mg/kg of SAR441236, administered as a subcutaneous (SC) injection(s) on Day 0 (Cohort 10). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 1 mg/kg SAR441236 Participants continued non-study-provided ART and received 1 mg/kg of SAR441236, administered as an SC injection(s) on Day 0 (Cohort 11). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0 mg/kg SAR441236 Placebo participants were pooled across those receiving: * 0.3 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 10). * 1 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 11). All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)
Mean Maximum Concentration (Cmax) of SAR441236 After a Single IV Infusion or SC Injection.	25.2 (ug/mL) Standard Error 11	72.7 (ug/mL) Standard Error 27.7	295 (ug/mL) Standard Error 265	771 (ug/mL) Standard Error 250	24.9 (ug/mL) Standard Error 3.5	483 (ug/mL) Standard Error 249	1.69 (ug/mL) Standard Error 0.74	4.77 (ug/mL) Standard Error 2.32	—	—

SECONDARY outcome

Population: All participants exposed to SAR441236 with evaluable levels of SAR441236 such that half-life can be derived.

Half-life for each participant was calculated using regression analysis on all available SAR441236 concentrations measured prior to and after first treatment and prior to any subsequent treatment instances (Arm A: 30 mg/kg only). Standard noncompartmental techniques, using Phoenix WinNonlin, were used to determine half-life.

Outcome measures

Outcome measures
Measure	Arm A: 1 mg/kg SAR441236 n=4 Participants Participants continued on non-study-provided ART and received 1 mg/kg of SAR441236, administered as a single intravenous (IV) infusion on Day 0 (Cohort 1). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 3 mg/kg for SAR441236 n=4 Participants Experimental: Arm A: 3 mg/kg SAR441236 Participants continued on non-study-provided ART, and received 3 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 2). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 10 mg/kg SAR441236 n=4 Participants Participants continued non-study-provided ART and received 10 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 3). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 30 mg/kg SAR441236 n=9 Participants Participants continued non-study-provided ART and received 30 mg/kg of SAR441236, administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 0 mg/kg SAR441236 n=5 Participants Placebo participants were pooled across those receiving: * 1 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 1). * 3 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 2). * 10 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 3) * 30 mg/kg dose volume-equivalent administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4) All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 1 mg/kg SAR441236 n=2 Participants Participants received 1 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 5). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 30 mg/kg SAR441236 n=4 Participants Participants received 30 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 8). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0.3 mg/kg SAR441236 n=4 Participants Participants continued non-study-provided ART and received 0.3 mg/kg of SAR441236, administered as a subcutaneous (SC) injection(s) on Day 0 (Cohort 10). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 1 mg/kg SAR441236 Participants continued non-study-provided ART and received 1 mg/kg of SAR441236, administered as an SC injection(s) on Day 0 (Cohort 11). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0 mg/kg SAR441236 Placebo participants were pooled across those receiving: * 0.3 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 10). * 1 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 11). All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)
Half-life (T1/2) of SAR441236 After a Single IV Infusion or SC Injection.	34.8 (days) Standard Deviation 4.73	38.1 (days) Standard Deviation 4.94	30.9 (days) Standard Deviation 4.90	37.0 (days) Standard Deviation 6.46	27.2 (days) Standard Deviation 2.37	23.2 (days) Standard Deviation 3.97	58.5 (days) Standard Deviation 1.41	47.7 (days) Standard Deviation 6.13	—	—

SECONDARY outcome

Population: All participants exposed to SAR441236 with evaluable levels of SAR441236 such that Cmax, and corresponding Tmax, can be derived.

Tmax for each participant was time to maximum observed SAR441236 measured from all available SAR441236 concentrations measured prior to and after first treatment and prior to any subsequent treatment instances (Arm A: 30 mg/kg only). Standard noncompartmental techniques, using Phoenix WinNonlin, were used to determine Tmax.

Outcome measures

Outcome measures
Measure	Arm A: 1 mg/kg SAR441236 n=4 Participants Participants continued on non-study-provided ART and received 1 mg/kg of SAR441236, administered as a single intravenous (IV) infusion on Day 0 (Cohort 1). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 3 mg/kg for SAR441236 n=4 Participants Experimental: Arm A: 3 mg/kg SAR441236 Participants continued on non-study-provided ART, and received 3 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 2). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 10 mg/kg SAR441236 n=4 Participants Participants continued non-study-provided ART and received 10 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 3). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 30 mg/kg SAR441236 n=9 Participants Participants continued non-study-provided ART and received 30 mg/kg of SAR441236, administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 0 mg/kg SAR441236 n=5 Participants Placebo participants were pooled across those receiving: * 1 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 1). * 3 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 2). * 10 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 3) * 30 mg/kg dose volume-equivalent administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4) All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 1 mg/kg SAR441236 n=2 Participants Participants received 1 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 5). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 30 mg/kg SAR441236 n=4 Participants Participants received 30 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 8). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0.3 mg/kg SAR441236 n=4 Participants Participants continued non-study-provided ART and received 0.3 mg/kg of SAR441236, administered as a subcutaneous (SC) injection(s) on Day 0 (Cohort 10). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 1 mg/kg SAR441236 Participants continued non-study-provided ART and received 1 mg/kg of SAR441236, administered as an SC injection(s) on Day 0 (Cohort 11). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0 mg/kg SAR441236 Placebo participants were pooled across those receiving: * 0.3 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 10). * 1 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 11). All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)
Time to Maximum Concentration (Tmax) of SAR441236 After a Single IV Infusion of SC Injection.	0.07 (days) Standard Error 0.05	2.11 (days) Standard Error 4.06	0.12 (days) Standard Error 0.08	0.16 (days) Standard Error 0.15	0.09 (days) Standard Error 0.12	0.09 (days) Standard Error 0.06	6.71 (days) Standard Error 5.19	5.07 (days) Standard Error 2.49	—	—

SECONDARY outcome

Population: All participants exposed to SAR441236 with evaluable levels of SAR441236 such that clearance (Arms A and B) or apparent clearance (Arm C) can be derived.

Clearance (CL, in Arms A and B) or Apparent Clearance (CL/F, in Arm C) for each participant was calculated from all available SAR441236 concentrations measured prior to and after first treatment and prior to any subsequent treatment instances (Arm A: 30 mg/kg only). Standard noncompartmental techniques, using Phoenix WinNonlin, were used to determine CL and CL/F.

Outcome measures

Outcome measures
Measure	Arm A: 1 mg/kg SAR441236 n=4 Participants Participants continued on non-study-provided ART and received 1 mg/kg of SAR441236, administered as a single intravenous (IV) infusion on Day 0 (Cohort 1). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 3 mg/kg for SAR441236 n=4 Participants Experimental: Arm A: 3 mg/kg SAR441236 Participants continued on non-study-provided ART, and received 3 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 2). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 10 mg/kg SAR441236 n=4 Participants Participants continued non-study-provided ART and received 10 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 3). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 30 mg/kg SAR441236 n=9 Participants Participants continued non-study-provided ART and received 30 mg/kg of SAR441236, administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 0 mg/kg SAR441236 n=5 Participants Placebo participants were pooled across those receiving: * 1 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 1). * 3 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 2). * 10 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 3) * 30 mg/kg dose volume-equivalent administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4) All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 1 mg/kg SAR441236 n=2 Participants Participants received 1 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 5). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 30 mg/kg SAR441236 n=4 Participants Participants received 30 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 8). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0.3 mg/kg SAR441236 n=4 Participants Participants continued non-study-provided ART and received 0.3 mg/kg of SAR441236, administered as a subcutaneous (SC) injection(s) on Day 0 (Cohort 10). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 1 mg/kg SAR441236 Participants continued non-study-provided ART and received 1 mg/kg of SAR441236, administered as an SC injection(s) on Day 0 (Cohort 11). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0 mg/kg SAR441236 Placebo participants were pooled across those receiving: * 0.3 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 10). * 1 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 11). All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)
Clearance or Apparent Clearance of SAR441236 After a Single IV Infusion of SC Injection.	181 (mL/day) Standard Deviation 148	116 (mL/day) Standard Deviation 14.9	130 (mL/day) Standard Deviation 43.5	122 (mL/day) Standard Deviation 50.2	132 (mL/day) Standard Deviation 28.1	348 (mL/day) Standard Deviation 51.6	163 (mL/day) Standard Deviation 36.0	399 (mL/day) Standard Deviation 318	—	—

SECONDARY outcome

Population: All participants exposed to SAR441236 with evaluable levels of SAR441236 such that volume of distribution (Arms A and B) or apparent volume of distribution (Arm C) can be derived.

Volume of distribution (Arms A and B) or apparent volume of distribution (Arm C) was calculated from all available SAR441236 concentrations measured prior to and after first treatment and prior to any subsequent treatment instances (Arm A: 30 mg/kg only). Standard noncompartmental techniques, using Phoenix WinNonlin, were used to determine volume of distribution and apparent volume of distribution.

Outcome measures

Outcome measures
Measure	Arm A: 1 mg/kg SAR441236 n=4 Participants Participants continued on non-study-provided ART and received 1 mg/kg of SAR441236, administered as a single intravenous (IV) infusion on Day 0 (Cohort 1). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 3 mg/kg for SAR441236 n=4 Participants Experimental: Arm A: 3 mg/kg SAR441236 Participants continued on non-study-provided ART, and received 3 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 2). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 10 mg/kg SAR441236 n=4 Participants Participants continued non-study-provided ART and received 10 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 3). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 30 mg/kg SAR441236 n=9 Participants Participants continued non-study-provided ART and received 30 mg/kg of SAR441236, administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 0 mg/kg SAR441236 n=5 Participants Placebo participants were pooled across those receiving: * 1 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 1). * 3 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 2). * 10 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 3) * 30 mg/kg dose volume-equivalent administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4) All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 1 mg/kg SAR441236 n=2 Participants Participants received 1 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 5). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 30 mg/kg SAR441236 n=4 Participants Participants received 30 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 8). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0.3 mg/kg SAR441236 n=4 Participants Participants continued non-study-provided ART and received 0.3 mg/kg of SAR441236, administered as a subcutaneous (SC) injection(s) on Day 0 (Cohort 10). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 1 mg/kg SAR441236 Participants continued non-study-provided ART and received 1 mg/kg of SAR441236, administered as an SC injection(s) on Day 0 (Cohort 11). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0 mg/kg SAR441236 Placebo participants were pooled across those receiving: * 0.3 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 10). * 1 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 11). All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)
Volume of Distribution of SAR441236 After a Single IV Infusion or SC Injection	8.02 (L) Standard Deviation 3.13	5.90 (L) Standard Deviation 1.56	5.34 (L) Standard Deviation 0.48	5.96 (L) Standard Deviation 1.05	5.27 (L) Standard Deviation 0.79	9.73 (L) Standard Deviation 0.38	14.0 (L) Standard Deviation 2.79	22.8 (L) Standard Deviation 14.7	—	—

SECONDARY outcome

Timeframe: Intensive SAR441236 PK samples after Infusion 4 (Week 36) at Hours 0, 2, 4, 6, and 10, Days 1 and 2, and at non-intensive sampling at Weeks 37, 38, 40, 48, 60, and 72.

Population: All participants exposed to 4 infusions of SASR441236 (30 mg/kg participants only) with evaluable levels of SAR441236 such that Cmax can be derived.

Cmax after the fourth infusion was calculated as the maximum observed SAR441236 concentration from SAR441236 PK samples obtained after the fourth infusion. Standard noncompartmental techniques, using Phoenix WinNonlin, were used to determine Cmax after the 4th infusion.

Outcome measures

Outcome measures
Measure	Arm A: 1 mg/kg SAR441236 n=6 Participants Participants continued on non-study-provided ART and received 1 mg/kg of SAR441236, administered as a single intravenous (IV) infusion on Day 0 (Cohort 1). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 3 mg/kg for SAR441236 Experimental: Arm A: 3 mg/kg SAR441236 Participants continued on non-study-provided ART, and received 3 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 2). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 10 mg/kg SAR441236 Participants continued non-study-provided ART and received 10 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 3). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 30 mg/kg SAR441236 Participants continued non-study-provided ART and received 30 mg/kg of SAR441236, administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 0 mg/kg SAR441236 Placebo participants were pooled across those receiving: * 1 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 1). * 3 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 2). * 10 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 3) * 30 mg/kg dose volume-equivalent administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4) All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 1 mg/kg SAR441236 Participants received 1 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 5). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 30 mg/kg SAR441236 Participants received 30 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 8). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0.3 mg/kg SAR441236 Participants continued non-study-provided ART and received 0.3 mg/kg of SAR441236, administered as a subcutaneous (SC) injection(s) on Day 0 (Cohort 10). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 1 mg/kg SAR441236 Participants continued non-study-provided ART and received 1 mg/kg of SAR441236, administered as an SC injection(s) on Day 0 (Cohort 11). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0 mg/kg SAR441236 Placebo participants were pooled across those receiving: * 0.3 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 10). * 1 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 11). All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)
Mean Maximum Concentration (Cmax) of SAR441236 After the Fourth IV Infusion	890.50 ug/mL Standard Deviation 176.66	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: SAR441236 PK samples at Week 12, 24, 36, and 48.

Population: All participants exposed to 4 infusions of SAR441236 (30 mg/kg participants only) with evaluable levels of SAR441236. Only participants who maintained the every 12-week dosing schedule were considered for concentration levels 12 weeks after infusions 2-4.

SAR441236 concentration for each participant was calculated as the observed SAR441236 concentration 12 weeks after each infusion.

Outcome measures

Outcome measures
Measure	Arm A: 1 mg/kg SAR441236 n=6 Participants Participants continued on non-study-provided ART and received 1 mg/kg of SAR441236, administered as a single intravenous (IV) infusion on Day 0 (Cohort 1). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 3 mg/kg for SAR441236 Experimental: Arm A: 3 mg/kg SAR441236 Participants continued on non-study-provided ART, and received 3 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 2). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 10 mg/kg SAR441236 Participants continued non-study-provided ART and received 10 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 3). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 30 mg/kg SAR441236 Participants continued non-study-provided ART and received 30 mg/kg of SAR441236, administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 0 mg/kg SAR441236 Placebo participants were pooled across those receiving: * 1 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 1). * 3 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 2). * 10 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 3) * 30 mg/kg dose volume-equivalent administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4) All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 1 mg/kg SAR441236 Participants received 1 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 5). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 30 mg/kg SAR441236 Participants received 30 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 8). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0.3 mg/kg SAR441236 Participants continued non-study-provided ART and received 0.3 mg/kg of SAR441236, administered as a subcutaneous (SC) injection(s) on Day 0 (Cohort 10). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 1 mg/kg SAR441236 Participants continued non-study-provided ART and received 1 mg/kg of SAR441236, administered as an SC injection(s) on Day 0 (Cohort 11). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0 mg/kg SAR441236 Placebo participants were pooled across those receiving: * 0.3 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 10). * 1 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 11). All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)
Mean SAR441236 Concentration 12 Weeks After Infusions 1, 2, 3, and 4 SAR441236 Concentration at Infusion 1 + 12 Weeks	88.28 ug/mL Standard Deviation 46.73	—	—	—	—	—	—	—	—	—
Mean SAR441236 Concentration 12 Weeks After Infusions 1, 2, 3, and 4 SAR441236 Concentration at Infusion 2 + 12 Weeks	136.87 ug/mL Standard Deviation 48.78	—	—	—	—	—	—	—	—	—
Mean SAR441236 Concentration 12 Weeks After Infusions 1, 2, 3, and 4 SAR441236 Concentration at Infusion 3 + 12 Weeks	120.00 ug/mL Standard Deviation 40.84	—	—	—	—	—	—	—	—	—
Mean SAR441236 Concentration 12 Weeks After Infusions 1, 2, 3, and 4 SAR441236 Concentration at Infusion 4 + 12 Weeks	122.40 ug/mL Standard Deviation 45.43	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Intensive SAR441236 PK samples taken at Hours 0, 2, 4, 6, and 10 and Days 1 and 2 after infusions 1 and 4 and non-intensive sampling at pre-dose (Weeks 0, Week 12, 24, 36) and Weeks 2, 4 , 8, 10, 13, 14, 16, 22, 26, 28, 34, 37, 38, 40, and 48.

Area Under the Concentration time curve (AUC) for multiple infusions of SAR441236 was calculated using all available SAR441236 concentrations. Standard noncompartmental techniques, using Phoenix WinNonlin, were used to determine AUC.

Outcome measures

Outcome measures
Measure	Arm A: 1 mg/kg SAR441236 n=3 Participants Participants continued on non-study-provided ART and received 1 mg/kg of SAR441236, administered as a single intravenous (IV) infusion on Day 0 (Cohort 1). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 3 mg/kg for SAR441236 Experimental: Arm A: 3 mg/kg SAR441236 Participants continued on non-study-provided ART, and received 3 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 2). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 10 mg/kg SAR441236 Participants continued non-study-provided ART and received 10 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 3). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 30 mg/kg SAR441236 Participants continued non-study-provided ART and received 30 mg/kg of SAR441236, administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 0 mg/kg SAR441236 Placebo participants were pooled across those receiving: * 1 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 1). * 3 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 2). * 10 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 3) * 30 mg/kg dose volume-equivalent administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4) All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 1 mg/kg SAR441236 Participants received 1 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 5). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 30 mg/kg SAR441236 Participants received 30 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 8). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0.3 mg/kg SAR441236 Participants continued non-study-provided ART and received 0.3 mg/kg of SAR441236, administered as a subcutaneous (SC) injection(s) on Day 0 (Cohort 10). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 1 mg/kg SAR441236 Participants continued non-study-provided ART and received 1 mg/kg of SAR441236, administered as an SC injection(s) on Day 0 (Cohort 11). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0 mg/kg SAR441236 Placebo participants were pooled across those receiving: * 0.3 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 10). * 1 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 11). All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)
Mean AUC After Multiple Infusions of SAR441236 AUC 24-36 Week	21809.83 (ug*day)/mL Standard Deviation 7210.58	—	—	—	—	—	—	—	—	—
Mean AUC After Multiple Infusions of SAR441236 AUC 12-24 Week	26508.02 (ug*day)/mL Standard Deviation 5914.53	—	—	—	—	—	—	—	—	—
Mean AUC After Multiple Infusions of SAR441236 AUC 36-48 Week	26137.06 (ug*day)/mL Standard Deviation 5336.72	—	—	—	—	—	—	—	—	—
Mean AUC After Multiple Infusions of SAR441236 AUC 0-48 Week	96277.43 (ug*day)/mL Standard Deviation 17105.70	—	—	—	—	—	—	—	—	—

SECONDARY outcome

The AUC AI (12 Weeks post-Dose 1 vs 12 Weeks post-Dose 4) was calculated as the ratio of AUC 36-48 Weeks and AUC 0-12 Weeks. Standard noncompartmental techniques, using Phoenix WinNonlin, were used to determine AUC AI.

Outcome measures

Outcome measures
Measure	Arm A: 1 mg/kg SAR441236 n=3 Participants Participants continued on non-study-provided ART and received 1 mg/kg of SAR441236, administered as a single intravenous (IV) infusion on Day 0 (Cohort 1). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 3 mg/kg for SAR441236 Experimental: Arm A: 3 mg/kg SAR441236 Participants continued on non-study-provided ART, and received 3 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 2). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 10 mg/kg SAR441236 Participants continued non-study-provided ART and received 10 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 3). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 30 mg/kg SAR441236 Participants continued non-study-provided ART and received 30 mg/kg of SAR441236, administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 0 mg/kg SAR441236 Placebo participants were pooled across those receiving: * 1 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 1). * 3 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 2). * 10 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 3) * 30 mg/kg dose volume-equivalent administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4) All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 1 mg/kg SAR441236 Participants received 1 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 5). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 30 mg/kg SAR441236 Participants received 30 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 8). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0.3 mg/kg SAR441236 Participants continued non-study-provided ART and received 0.3 mg/kg of SAR441236, administered as a subcutaneous (SC) injection(s) on Day 0 (Cohort 10). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 1 mg/kg SAR441236 Participants continued non-study-provided ART and received 1 mg/kg of SAR441236, administered as an SC injection(s) on Day 0 (Cohort 11). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0 mg/kg SAR441236 Placebo participants were pooled across those receiving: * 0.3 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 10). * 1 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 11). All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)
Mean AUC Accumulation Index (AI) (12 Weeks Post-Dose 1 vs 12 Weeks Post-Dose 4).	1.24 Ratio Standard Deviation 0.18	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: SAR441236 PK samples taken at Week 12 (pre-dose #2) and at Week 48 (12 weeks after dose #4)

The Trough AI was calculated as the ratio of the SAR441236 concentration observed 12 weeks after the 4th dose and the SAR441236 concentration observed 12 weeks after the 1st dose. Standard noncompartmental techniques, using Phoenix WinNonlin, were used to determine trough AI.

Outcome measures

Outcome measures
Measure	Arm A: 1 mg/kg SAR441236 n=3 Participants Participants continued on non-study-provided ART and received 1 mg/kg of SAR441236, administered as a single intravenous (IV) infusion on Day 0 (Cohort 1). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 3 mg/kg for SAR441236 Experimental: Arm A: 3 mg/kg SAR441236 Participants continued on non-study-provided ART, and received 3 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 2). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 10 mg/kg SAR441236 Participants continued non-study-provided ART and received 10 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 3). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 30 mg/kg SAR441236 Participants continued non-study-provided ART and received 30 mg/kg of SAR441236, administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 0 mg/kg SAR441236 Placebo participants were pooled across those receiving: * 1 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 1). * 3 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 2). * 10 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 3) * 30 mg/kg dose volume-equivalent administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4) All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 1 mg/kg SAR441236 Participants received 1 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 5). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 30 mg/kg SAR441236 Participants received 30 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 8). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0.3 mg/kg SAR441236 Participants continued non-study-provided ART and received 0.3 mg/kg of SAR441236, administered as a subcutaneous (SC) injection(s) on Day 0 (Cohort 10). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 1 mg/kg SAR441236 Participants continued non-study-provided ART and received 1 mg/kg of SAR441236, administered as an SC injection(s) on Day 0 (Cohort 11). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0 mg/kg SAR441236 Placebo participants were pooled across those receiving: * 0.3 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 10). * 1 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 11). All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)
Mean Trough Accumulative Index (12 Weeks Post-Dose 1 vs 12 Weeks Post-Dose 4)	1.13 Ratio Standard Deviation 0.04	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 0 and at all study visits prior to ART initiation/re-initiation (up to Week 4)

Population: Only Arm B participants (who were off ART and viremic at entry) were considered for this outcome. Summaries of viral response are provided in outcomes 3, 4, 5, and 6. However, the dose-response relationship cannot be modeled due to insufficient sample size.

This relationship is based on measured SAR441236 concentrations and HIV-1 RNA values prior to participants initiating ART.

Outcome measures

Outcome data not reported

Adverse Events

Arm A: 1mg/kg SAR441236

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Arm A: 3 mg/kg SAR441236

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Arm A: 10 mg/kg SAR441236

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Arm A: 30 mg/kg SAR441236

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

Arm A: 0 mg/kg SAR441236

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Arm B: 1 mg/kg SAR441236

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Arm B: 30 mg/kg SAR441236

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm C: 0.3 mg/kg SAR441236

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Arm C: 1 mg/kg SAR441236

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Arm C: 0 mg/kg SAR441236

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm A: 1mg/kg SAR441236 n=4 participants at risk Participants continued on non-study-provided ART and received 1 mg/kg of SAR441236, administered as a single intravenous (IV) infusion on Day 0 (Cohort 1). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 3 mg/kg SAR441236 n=4 participants at risk Experimental: Arm A: 3 mg/kg SAR441236 Participants continued on non-study-provided ART, and received 3 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 2). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 10 mg/kg SAR441236 n=4 participants at risk Participants continued non-study-provided ART and received 10 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 3). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 30 mg/kg SAR441236 n=11 participants at risk Participants continued non-study-provided ART and received 30 mg/kg of SAR441236, administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 0 mg/kg SAR441236 n=10 participants at risk Placebo participants were pooled across those receiving: * 1 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 1). * 3 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 2). * 10 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 3) * 30 mg/kg dose volume-equivalent administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4) All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 1 mg/kg SAR441236 n=5 participants at risk Participants received 1 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 5). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 30 mg/kg SAR441236 n=2 participants at risk Participants received 30 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 8). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0.3 mg/kg SAR441236 n=4 participants at risk Participants continued non-study-provided ART and received 0.3 mg/kg of SAR441236, administered as a subcutaneous (SC) injection(s) on Day 0 (Cohort 10). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 1 mg/kg SAR441236 n=4 participants at risk Participants continued non-study-provided ART and received 1 mg/kg of SAR441236, administered as an SC injection(s) on Day 0 (Cohort 11). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0 mg/kg SAR441236 n=4 participants at risk Placebo participants were pooled across those receiving: * 0.3 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 10). * 1 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 11). All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)
Infections and infestations Pneumonia	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	9.1% 1/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Infections and infestations Soft tissue infection	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	20.0% 1/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	25.0% 1/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Psychiatric disorders Suicidal ideation	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	9.1% 1/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration

Other adverse events

Other adverse events
Measure	Arm A: 1mg/kg SAR441236 n=4 participants at risk Participants continued on non-study-provided ART and received 1 mg/kg of SAR441236, administered as a single intravenous (IV) infusion on Day 0 (Cohort 1). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 3 mg/kg SAR441236 n=4 participants at risk Experimental: Arm A: 3 mg/kg SAR441236 Participants continued on non-study-provided ART, and received 3 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 2). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 10 mg/kg SAR441236 n=4 participants at risk Participants continued non-study-provided ART and received 10 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 3). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 30 mg/kg SAR441236 n=11 participants at risk Participants continued non-study-provided ART and received 30 mg/kg of SAR441236, administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm A: 0 mg/kg SAR441236 n=10 participants at risk Placebo participants were pooled across those receiving: * 1 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 1). * 3 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 2). * 10 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 3) * 30 mg/kg dose volume-equivalent administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4) All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 1 mg/kg SAR441236 n=5 participants at risk Participants received 1 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 5). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm B: 30 mg/kg SAR441236 n=2 participants at risk Participants received 30 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 8). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0.3 mg/kg SAR441236 n=4 participants at risk Participants continued non-study-provided ART and received 0.3 mg/kg of SAR441236, administered as a subcutaneous (SC) injection(s) on Day 0 (Cohort 10). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 1 mg/kg SAR441236 n=4 participants at risk Participants continued non-study-provided ART and received 1 mg/kg of SAR441236, administered as an SC injection(s) on Day 0 (Cohort 11). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)	Arm C: 0 mg/kg SAR441236 n=4 participants at risk Placebo participants were pooled across those receiving: * 0.3 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 10). * 1 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 11). All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)
Ear and labyrinth disorders External ear pain	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	20.0% 1/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Gastrointestinal disorders Abdominal pain	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	25.0% 1/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	25.0% 1/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Gastrointestinal disorders Abdominal pain upper	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	25.0% 1/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Gastrointestinal disorders Diarrhoea	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	9.1% 1/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	9.1% 1/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Gastrointestinal disorders Nausea	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	25.0% 1/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	20.0% 1/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
General disorders Asthenia	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	25.0% 1/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
General disorders Chills	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	25.0% 1/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
General disorders Fatigue	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	50.0% 2/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
General disorders Injection site erythema	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	25.0% 1/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
General disorders Injection site swelling	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	25.0% 1/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
General disorders Localised oedema	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	20.0% 1/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
General disorders Malaise	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	9.1% 1/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
General disorders Oedema peripheral	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	9.1% 1/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
General disorders Pain	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	25.0% 1/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Infections and infestations Bronchitis	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	10.0% 1/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Infections and infestations Cellulitis	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	9.1% 1/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Infections and infestations Fungal foot infection	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	20.0% 1/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Infections and infestations Fungal skin infection	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	20.0% 1/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Infections and infestations Influenza	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	25.0% 1/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Infections and infestations Otitis media	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	25.0% 1/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Infections and infestations Pharyngitis streptococcal	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	25.0% 1/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Infections and infestations Tooth infection	25.0% 1/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Infections and infestations Upper respiratory tract infection	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	9.1% 1/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	20.0% 1/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	20.0% 1/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Injury, poisoning and procedural complications Skin laceration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	9.1% 1/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	20.0% 1/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Investigations Alanine aminotransferase increased	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	9.1% 1/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	40.0% 2/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Investigations Blood bicarbonate decreased	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	9.1% 1/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	10.0% 1/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Investigations Aspartate aminotransferase increased	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	25.0% 1/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	9.1% 1/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	20.0% 1/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	25.0% 1/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Investigations Blood albumin decreased	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	9.1% 1/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Investigations Blood creatinine increased	25.0% 1/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	25.0% 1/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	45.5% 5/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	10.0% 1/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	40.0% 2/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Musculoskeletal and connective tissue disorders Trigger finger	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	9.1% 1/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Investigations Blood glucose increased	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	45.5% 5/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	10.0% 1/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	25.0% 1/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Investigations Blood sodium increased	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	10.0% 1/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Investigations Blood uric acid increased	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	27.3% 3/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Investigations Creatinine renal clearance decreased	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	50.0% 2/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	50.0% 2/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	54.5% 6/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	80.0% 8/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	80.0% 4/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	50.0% 2/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	75.0% 3/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Investigations Neutrophil count decreased	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	10.0% 1/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Metabolism and nutrition disorders Decreased appetite	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	25.0% 1/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	25.0% 1/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	25.0% 1/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Nervous system disorders Diabetic neuropathy	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	9.1% 1/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	10.0% 1/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	9.1% 1/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	10.0% 1/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	10.0% 1/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	9.1% 1/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	10.0% 1/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Nervous system disorders Headache	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	18.2% 2/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	10.0% 1/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Nervous system disorders Hypoaesthesia	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	25.0% 1/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Nervous system disorders Paraesthesia	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	25.0% 1/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Nervous system disorders Parkinson's disease	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	10.0% 1/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	25.0% 1/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	9.1% 1/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	20.0% 1/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Nervous system disorders Presyncope	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	25.0% 1/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Nervous system disorders Seizure	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	20.0% 1/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Nervous system disorders Somnolence	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	25.0% 1/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Psychiatric disorders Alcohol withdrawal syndrome	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	9.1% 1/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Psychiatric disorders Insomnia	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	9.1% 1/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Renal and urinary disorders Glycosuria	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	9.1% 1/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	25.0% 1/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	9.1% 1/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	9.1% 1/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Skin and subcutaneous tissue disorders Rash	25.0% 1/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Vascular disorders Hot flush	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	25.0% 1/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/11 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/10 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/5 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/2 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration	0.00% 0/4 • From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation. The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if: * Grade ≥2 AE * Any AE leading to change in study treatment * AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement * Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration

Additional Information

ACTG Clinicaltrials.gov Coordinator

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Phone: (301) 628-3348

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place