Trial Outcomes & Findings for Safety and Virologic Effect of a Human Monoclonal Antibody (VRC01) Administered Intravenously to Adults During Early Acute HIV Infection (NCT NCT02591420)

Last Updated: 2025-12-17

Results Overview

This outcome is the combined total number of grade 3 or higher mAb-related reactogenicity events and mAb-related adverse events for each group. Only grade 3 reactogenicity events/AEs that are determined by the study physicians to be related to mAb are included. Adverse events, including reactogenicity events, are graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events v2.0 dated November 2014. This outcome is the total number of solicited adverse events (reactogenicity events) that had a severity of grade 3 or higher and were related to the mAb. Note that higher grades indicate worse severity.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

24 participants

Primary outcome timeframe

Measured through Week 24

Results posted on

2025-12-17

Participant Flow

Participant milestones

Participant milestones
Measure	Group 1: Immediate ART and Placebo Infusion Participants will start ART and will receive a single infusion of placebo at Day 0. Placebo for VRC01: Administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.	Group 2: Immediate ART and VRC01 Infusion Participants will start ART and receive a single infusion of VRC01 at Day 0. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.	Group 3: Immediate VRC01 Infusion and Subsequent ART Participants will receive a single infusion of VRC01 on Day 0 followed by ART initiation on Day 7. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.
Overall Study STARTED	8	8	8
Overall Study COMPLETED	8	7	6
Overall Study NOT COMPLETED	0	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1: Immediate ART and Placebo Infusion Participants will start ART and will receive a single infusion of placebo at Day 0. Placebo for VRC01: Administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.	Group 2: Immediate ART and VRC01 Infusion Participants will start ART and receive a single infusion of VRC01 at Day 0. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.	Group 3: Immediate VRC01 Infusion and Subsequent ART Participants will receive a single infusion of VRC01 on Day 0 followed by ART initiation on Day 7. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.
Overall Study Lost to Follow-up	0	1	2

Baseline Characteristics

Safety and Virologic Effect of a Human Monoclonal Antibody (VRC01) Administered Intravenously to Adults During Early Acute HIV Infection

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Measured through Week 24

Population: All randomized participants

Outcome measures

Outcome measures
Measure	Group 3: Immediate VRC01 Infusion and Subsequent ART n=8 Participants Participants will receive a single infusion of VRC01 on Day 0 followed by ART initiation on Day 7. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.	Group 1: Immediate ART and Placebo Infusion n=8 Participants Participants will start ART and will receive a single infusion of placebo at Day 0. Placebo for VRC01: Administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.	Group 2: Immediate ART and VRC01 Infusion n=8 Participants Participants will start ART and receive a single infusion of VRC01 at Day 0. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.
Number of Participants With Grade 3 or Greater mAb-related Reactogenicity and mAb-related Adverse Events (AEs)	1 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Measured through Day 7

Population: All randomized participants

Outcome measures

Outcome measures
Measure	Group 3: Immediate VRC01 Infusion and Subsequent ART n=8 Participants Participants will receive a single infusion of VRC01 on Day 0 followed by ART initiation on Day 7. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.	Group 1: Immediate ART and Placebo Infusion n=8 Participants Participants will start ART and will receive a single infusion of placebo at Day 0. Placebo for VRC01: Administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.	Group 2: Immediate ART and VRC01 Infusion n=8 Participants Participants will start ART and receive a single infusion of VRC01 at Day 0. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.
Plasma Viral Load Change From Day 0 to Day 7	-0.2336 log(copies/mL) Standard Deviation 0.9635	-1.5238 log(copies/mL) Standard Deviation 0.8018	-1.6108 log(copies/mL) Standard Deviation 0.8174

SECONDARY outcome

Timeframe: Measured through Week 24

Population: All randomized participants

Outcome measures

Outcome measures
Measure	Group 3: Immediate VRC01 Infusion and Subsequent ART n=8 Participants Participants will receive a single infusion of VRC01 on Day 0 followed by ART initiation on Day 7. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.	Group 1: Immediate ART and Placebo Infusion n=8 Participants Participants will start ART and will receive a single infusion of placebo at Day 0. Placebo for VRC01: Administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.	Group 2: Immediate ART and VRC01 Infusion n=8 Participants Participants will start ART and receive a single infusion of VRC01 at Day 0. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.
Time to Virologic Suppression (Less Than 50 Copies/ml) in Plasma	87.0 Days Interval 29.0 to The upper limit of the confidence interval was not estimable because all participants considered failures for this endpoint withdrew from the study prior to reaching the \<50 copies/mL threshold	58.0 Days Interval 13.0 to 162.0	43.5 Days Interval 14.0 to The upper limit of the confidence interval was not estimable because all participants considered failures for this endpoint withdrew from the study prior to reaching the \<50 copies/mL threshold

SECONDARY outcome

Timeframe: Measured through Week 24

Population: All randomized participants

Outcome measures

Outcome measures
Measure	Group 3: Immediate VRC01 Infusion and Subsequent ART n=8 Participants Participants will receive a single infusion of VRC01 on Day 0 followed by ART initiation on Day 7. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.	Group 1: Immediate ART and Placebo Infusion n=8 Participants Participants will start ART and will receive a single infusion of placebo at Day 0. Placebo for VRC01: Administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.	Group 2: Immediate ART and VRC01 Infusion n=8 Participants Participants will start ART and receive a single infusion of VRC01 at Day 0. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.
Number of Total Viremic Copy Days (Area Under Viral Load Curve) From Day 0 to Week 24	2.34 days Interval 1.69 to 3.18	1.81 days Interval 1.44 to 2.22	1.74 days Interval 1.31 to 2.25

SECONDARY outcome

Timeframe: Measured through Week 24

In samples with HIV RNA less than 50 copies/ml at Day 7, Day 14, and Week 24

Outcome measures

Outcome measures
Measure	Group 3: Immediate VRC01 Infusion and Subsequent ART n=8 Participants Participants will receive a single infusion of VRC01 on Day 0 followed by ART initiation on Day 7. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.	Group 1: Immediate ART and Placebo Infusion n=8 Participants Participants will start ART and will receive a single infusion of placebo at Day 0. Placebo for VRC01: Administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.	Group 2: Immediate ART and VRC01 Infusion n=8 Participants Participants will start ART and receive a single infusion of VRC01 at Day 0. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.
Measurement of Plasma Viremia Including Single Copy HIV RNA Quantification Day 7	5.3417 log-10(copies/mL) Interval 4.9594 to 5.7843	4.2877 log-10(copies/mL) Interval 3.7054 to 4.8906	4.0632 log-10(copies/mL) Interval 3.5284 to 4.5666
Measurement of Plasma Viremia Including Single Copy HIV RNA Quantification Day 14	3.6189 log-10(copies/mL) Interval 3.1457 to 4.0278	3.2345 log-10(copies/mL) Interval 2.4737 to 3.9592	3.0389 log-10(copies/mL) Interval 2.3121 to 3.7925
Measurement of Plasma Viremia Including Single Copy HIV RNA Quantification Week 24 (Day 168)	0.7993 log-10(copies/mL) Interval 0.699 to 1.0	0.9223 log-10(copies/mL) Interval 0.7586 to 1.1457	0.9035 log-10(copies/mL) Interval 0.7671 to 1.1079

SECONDARY outcome

Timeframe: Measured through Week 24 (Day 168)

Population: Virologic population consists of all randomized participants.

Outcome measures

Outcome measures
Measure	Group 3: Immediate VRC01 Infusion and Subsequent ART n=7 Participants Participants will receive a single infusion of VRC01 on Day 0 followed by ART initiation on Day 7. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.	Group 1: Immediate ART and Placebo Infusion n=8 Participants Participants will start ART and will receive a single infusion of placebo at Day 0. Placebo for VRC01: Administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.	Group 2: Immediate ART and VRC01 Infusion n=7 Participants Participants will start ART and receive a single infusion of VRC01 at Day 0. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.
Measurement of Cell-associated HIV RNA and DNA in the Peripheral Compartment Day 0	3.940 log10 copies/mL Standard Deviation 1.298	4.036 log10 copies/mL Standard Deviation 0.950	3.214 log10 copies/mL Standard Deviation 1.571
Measurement of Cell-associated HIV RNA and DNA in the Peripheral Compartment Day 3	4.090 log10 copies/mL Standard Deviation 0.432	3.427 log10 copies/mL Standard Deviation 1.268	3.553 log10 copies/mL Standard Deviation 0.561
Measurement of Cell-associated HIV RNA and DNA in the Peripheral Compartment Day 7	3.924 log10 copies/mL Standard Deviation 0.482	3.690 log10 copies/mL Standard Deviation 0.708	2.780 log10 copies/mL Standard Deviation 0.979
Measurement of Cell-associated HIV RNA and DNA in the Peripheral Compartment Day 28	2.823 log10 copies/mL Standard Deviation 1.309	2.821 log10 copies/mL Standard Deviation 1.357	2.095 log10 copies/mL Standard Deviation 1.296
Measurement of Cell-associated HIV RNA and DNA in the Peripheral Compartment Day 168	2.656 log10 copies/mL Standard Deviation 0.768	2.169 log10 copies/mL Standard Deviation 1.516	1.283 log10 copies/mL Standard Deviation 1.616

SECONDARY outcome

Timeframe: Measured through Week 24

Outcome measures

Outcome measures
Measure	Group 3: Immediate VRC01 Infusion and Subsequent ART n=8 Participants Participants will receive a single infusion of VRC01 on Day 0 followed by ART initiation on Day 7. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.	Group 1: Immediate ART and Placebo Infusion n=8 Participants Participants will start ART and will receive a single infusion of placebo at Day 0. Placebo for VRC01: Administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.	Group 2: Immediate ART and VRC01 Infusion n=8 Participants Participants will start ART and receive a single infusion of VRC01 at Day 0. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.
Percentage of Participants Experiencing Acute Retroviral Syndrome	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Measured through Week 24

Outcome measures

Outcome measures
Measure	Group 3: Immediate VRC01 Infusion and Subsequent ART n=8 Participants Participants will receive a single infusion of VRC01 on Day 0 followed by ART initiation on Day 7. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.	Group 1: Immediate ART and Placebo Infusion n=8 Participants Participants will start ART and will receive a single infusion of placebo at Day 0. Placebo for VRC01: Administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.	Group 2: Immediate ART and VRC01 Infusion n=8 Participants Participants will start ART and receive a single infusion of VRC01 at Day 0. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.
Percentage of Participants Experiencing a Hospitalization	1 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Measured through Week 24

Outcome measures

Outcome measures
Measure	Group 3: Immediate VRC01 Infusion and Subsequent ART n=8 Participants Participants will receive a single infusion of VRC01 on Day 0 followed by ART initiation on Day 7. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.	Group 1: Immediate ART and Placebo Infusion n=8 Participants Participants will start ART and will receive a single infusion of placebo at Day 0. Placebo for VRC01: Administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.	Group 2: Immediate ART and VRC01 Infusion n=8 Participants Participants will start ART and receive a single infusion of VRC01 at Day 0. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.
Percentage of Participants Experiencing Opportunistic Infections	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Measured through Week 24

Outcome measures

Outcome measures
Measure	Group 3: Immediate VRC01 Infusion and Subsequent ART n=8 Participants Participants will receive a single infusion of VRC01 on Day 0 followed by ART initiation on Day 7. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.	Group 1: Immediate ART and Placebo Infusion n=8 Participants Participants will start ART and will receive a single infusion of placebo at Day 0. Placebo for VRC01: Administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.	Group 2: Immediate ART and VRC01 Infusion n=8 Participants Participants will start ART and receive a single infusion of VRC01 at Day 0. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.
Percentage of Participants Experiencing Non-AIDS-related Conditions	7 Participants	8 Participants	7 Participants

SECONDARY outcome

Timeframe: Measured through Week 24

Population: Change is analyzed using participants with data at both time points.

Decrease from baseline to nadir, increase from nadir to Week 24, and overall change from baseline to Week 24

Outcome measures

Outcome measures
Measure	Group 3: Immediate VRC01 Infusion and Subsequent ART n=8 Participants Participants will receive a single infusion of VRC01 on Day 0 followed by ART initiation on Day 7. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.	Group 1: Immediate ART and Placebo Infusion n=8 Participants Participants will start ART and will receive a single infusion of placebo at Day 0. Placebo for VRC01: Administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.	Group 2: Immediate ART and VRC01 Infusion n=8 Participants Participants will start ART and receive a single infusion of VRC01 at Day 0. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.
Measurement of CD4 + T Cells Change from Baseline to Nadir	-42.209 cells/microLiter Interval -90.054 to -5.571	-84.034 cells/microLiter Interval -176.61 to -14.217	-47.206 cells/microLiter Interval -99.143 to -6.206
Measurement of CD4 + T Cells Change from Nadir to Day 168	226.995 cells/microLiter Interval 97.837 to 356.153	381.398 cells/microLiter Interval 216.101 to 561.613	343.764 cells/microLiter Interval 126.938 to 600.48
Measurement of CD4 + T Cells Change from Baseline to Day 168	254.594 cells/microLiter Interval 70.404 to 380.18	336.134 cells/microLiter Interval 118.637 to 566.003	333.485 cells/microLiter Interval 74.122 to 622.0

SECONDARY outcome

Timeframe: Measured through Week 24

Population: The analysis population for this outcome is defined as those in the virologic population who have available samples for measuring the amount of VRC01 in the peripheral compartment. Some participants did not have samples available for the PK analysis.

Outcome measures

Outcome measures
Measure	Group 3: Immediate VRC01 Infusion and Subsequent ART n=8 Participants Participants will receive a single infusion of VRC01 on Day 0 followed by ART initiation on Day 7. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.	Group 1: Immediate ART and Placebo Infusion n=8 Participants Participants will start ART and will receive a single infusion of placebo at Day 0. Placebo for VRC01: Administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.	Group 2: Immediate ART and VRC01 Infusion n=8 Participants Participants will start ART and receive a single infusion of VRC01 at Day 0. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.
Measurement of VRC01 Levels in Peripheral Blood Day 7	156.043 ng/mL Standard Deviation 51.723	0 ng/mL Standard Deviation 0	169.288 ng/mL Standard Deviation 46.161
Measurement of VRC01 Levels in Peripheral Blood Day 14	87.750 ng/mL Standard Deviation 32.660	0 ng/mL Standard Deviation 0	91.275 ng/mL Standard Deviation 27.295
Measurement of VRC01 Levels in Peripheral Blood Day 3	259.600 ng/mL Standard Deviation 90.044	0 ng/mL Standard Deviation 0	276.813 ng/mL Standard Deviation 81.678
Measurement of VRC01 Levels in Peripheral Blood Day 21	47.717 ng/mL Standard Deviation 20.103	0 ng/mL Standard Deviation 0	58.583 ng/mL Standard Deviation 17.117
Measurement of VRC01 Levels in Peripheral Blood Day 28	32.850 ng/mL Standard Deviation 16.682	0 ng/mL Standard Deviation 0	37.438 ng/mL Standard Deviation 19.377
Measurement of VRC01 Levels in Peripheral Blood Day 56	7.933 ng/mL Standard Deviation 8.500	0 ng/mL Standard Deviation 0	13.800 ng/mL Standard Deviation 16.716
Measurement of VRC01 Levels in Peripheral Blood Day 168	3.350 ng/mL Standard Deviation 8.206	0 ng/mL Standard Deviation 0	0 ng/mL Standard Deviation 0
Measurement of VRC01 Levels in Peripheral Blood Day 1 (Pre)	0 ng/mL Standard Deviation 0	0 ng/mL Standard Deviation 0	0 ng/mL Standard Deviation 0
Measurement of VRC01 Levels in Peripheral Blood Day 1 (Post)	741.250 ng/mL Standard Deviation 458.083	0 ng/mL Standard Deviation 0	1136.667 ng/mL Standard Deviation 303.078

Adverse Events

Group 1: Immediate ART and Placebo Infusion

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

Group 2: Immediate ART and VRC01 Infusion

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Group 3: Immediate VRC01 Infusion and Subsequent ART

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group 1: Immediate ART and Placebo Infusion n=8 participants at risk Participants will start ART and will receive a single infusion of placebo at Day 0. Placebo for VRC01: Administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.	Group 2: Immediate ART and VRC01 Infusion n=8 participants at risk Participants will start ART and receive a single infusion of VRC01 at Day 0. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.	Group 3: Immediate VRC01 Infusion and Subsequent ART n=8 participants at risk Participants will receive a single infusion of VRC01 on Day 0 followed by ART initiation on Day 7. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.
Injury, poisoning and procedural complications Post procedural complication	12.5% 1/8 • Number of events 1 • Adverse event data are collected through 175 days after study agent administration. MedDRA version 21.2 was used. The site clinical research team will ascertain accurate recording of AEs on a daily basis. The clinical investigators will monitor and analyze study data as they become available and will make determinations regarding the severity of the adverse experiences and their relation to study product.	0.00% 0/8 • Adverse event data are collected through 175 days after study agent administration. MedDRA version 21.2 was used. The site clinical research team will ascertain accurate recording of AEs on a daily basis. The clinical investigators will monitor and analyze study data as they become available and will make determinations regarding the severity of the adverse experiences and their relation to study product.	0.00% 0/8 • Adverse event data are collected through 175 days after study agent administration. MedDRA version 21.2 was used. The site clinical research team will ascertain accurate recording of AEs on a daily basis. The clinical investigators will monitor and analyze study data as they become available and will make determinations regarding the severity of the adverse experiences and their relation to study product.
Surgical and medical procedures Anal fistula repair	12.5% 1/8 • Number of events 1 • Adverse event data are collected through 175 days after study agent administration. MedDRA version 21.2 was used. The site clinical research team will ascertain accurate recording of AEs on a daily basis. The clinical investigators will monitor and analyze study data as they become available and will make determinations regarding the severity of the adverse experiences and their relation to study product.	0.00% 0/8 • Adverse event data are collected through 175 days after study agent administration. MedDRA version 21.2 was used. The site clinical research team will ascertain accurate recording of AEs on a daily basis. The clinical investigators will monitor and analyze study data as they become available and will make determinations regarding the severity of the adverse experiences and their relation to study product.	0.00% 0/8 • Adverse event data are collected through 175 days after study agent administration. MedDRA version 21.2 was used. The site clinical research team will ascertain accurate recording of AEs on a daily basis. The clinical investigators will monitor and analyze study data as they become available and will make determinations regarding the severity of the adverse experiences and their relation to study product.
Nervous system disorders headache	0.00% 0/8 • Adverse event data are collected through 175 days after study agent administration. MedDRA version 21.2 was used. The site clinical research team will ascertain accurate recording of AEs on a daily basis. The clinical investigators will monitor and analyze study data as they become available and will make determinations regarding the severity of the adverse experiences and their relation to study product.	0.00% 0/8 • Adverse event data are collected through 175 days after study agent administration. MedDRA version 21.2 was used. The site clinical research team will ascertain accurate recording of AEs on a daily basis. The clinical investigators will monitor and analyze study data as they become available and will make determinations regarding the severity of the adverse experiences and their relation to study product.	12.5% 1/8 • Number of events 1 • Adverse event data are collected through 175 days after study agent administration. MedDRA version 21.2 was used. The site clinical research team will ascertain accurate recording of AEs on a daily basis. The clinical investigators will monitor and analyze study data as they become available and will make determinations regarding the severity of the adverse experiences and their relation to study product.

Other adverse events

Additional Information

Dr. Glenna Schluck

Data Coordinating and Analysis Center, HJF Global Infectious Diseases

Phone: 3015003824

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Group 1: Immediate ART and Placebo Infusion n=8 Participants Participants will start ART and will receive a single infusion of placebo at Day 0. Placebo for VRC01: Administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.	Group 2: Immediate ART and VRC01 Infusion n=8 Participants Participants will start ART and receive a single infusion of VRC01 at Day 0. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.	Group 3: Immediate VRC01 Infusion and Subsequent ART n=8 Participants Participants will receive a single infusion of VRC01 on Day 0 followed by ART initiation on Day 7. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.	Total n=24 Participants Total of all reporting groups
Race (NIH/OMB) Black or African American	3 Participants n=6 Participants	3 Participants n=5 Participants	3 Participants n=5 Participants	9 Participants n=122 Participants
Race (NIH/OMB) White	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=122 Participants
Age, Continuous	21.9 years STANDARD_DEVIATION 4.6 • n=6 Participants	23.5 years STANDARD_DEVIATION 3.2 • n=5 Participants	24.9 years STANDARD_DEVIATION 2.5 • n=5 Participants	23.4 years STANDARD_DEVIATION 3.6 • n=122 Participants
Sex/Gender, Customized Gender · Male	6 Participants n=6 Participants	4 Participants n=5 Participants	4 Participants n=5 Participants	14 Participants n=122 Participants
Sex/Gender, Customized Gender · Female	2 Participants n=6 Participants	3 Participants n=5 Participants	2 Participants n=5 Participants	7 Participants n=122 Participants
Sex/Gender, Customized Gender · Transgender	0 Participants n=6 Participants	1 Participants n=5 Participants	2 Participants n=5 Participants	3 Participants n=122 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=122 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=6 Participants	8 Participants n=5 Participants	8 Participants n=5 Participants	24 Participants n=122 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=122 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=122 Participants
Race (NIH/OMB) Asian	5 Participants n=6 Participants	5 Participants n=5 Participants	5 Participants n=5 Participants	15 Participants n=122 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=122 Participants
Race (NIH/OMB) More than one race	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=122 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=122 Participants
Region of Enrollment Tanzania	0 participants n=6 Participants	1 participants n=5 Participants	0 participants n=5 Participants	1 participants n=122 Participants
Region of Enrollment Uganda	1 participants n=6 Participants	0 participants n=5 Participants	1 participants n=5 Participants	2 participants n=122 Participants
Region of Enrollment Kenya	2 participants n=6 Participants	2 participants n=5 Participants	2 participants n=5 Participants	6 participants n=122 Participants
Region of Enrollment Thailand	5 participants n=6 Participants	5 participants n=5 Participants	5 participants n=5 Participants	15 participants n=122 Participants
Baseline Viral Load	5.8115 log10(copies/mL) STANDARD_DEVIATION 1.2286 • n=6 Participants	5.6740 log10(copies/mL) STANDARD_DEVIATION 0.8927 • n=5 Participants	5.5753 log10(copies/mL) STANDARD_DEVIATION 0.7120 • n=5 Participants	5.6869 log10(copies/mL) STANDARD_DEVIATION 0.9306 • n=122 Participants
Baseline CD4+ Count	595.724 cells/microLiter STANDARD_DEVIATION 252.350 • n=6 Participants	500.839 cells/microLiter STANDARD_DEVIATION 99.899 • n=5 Participants	410.991 cells/microLiter STANDARD_DEVIATION 158.902 • n=5 Participants	502.518 cells/microLiter STANDARD_DEVIATION 188.803 • n=122 Participants
Fiebig Stage Fiebig Stage 1	1 Participants n=6 Participants	1 Participants n=5 Participants	1 Participants n=5 Participants	3 Participants n=122 Participants
Fiebig Stage Fiebig Stage 2	3 Participants n=6 Participants	3 Participants n=5 Participants	3 Participants n=5 Participants	9 Participants n=122 Participants
Fiebig Stage Fiebig Stage 3	2 Participants n=6 Participants	3 Participants n=5 Participants	1 Participants n=5 Participants	6 Participants n=122 Participants
Fiebig Stage Fiebig Stage 4	1 Participants n=6 Participants	0 Participants n=5 Participants	3 Participants n=5 Participants	4 Participants n=122 Participants
Fiebig Stage Fiebig Stage 5	1 Participants n=6 Participants	1 Participants n=5 Participants	0 Participants n=5 Participants	2 Participants n=122 Participants