Trial Outcomes & Findings for Chloroquine for Reducing Immune Activation in HIV- Infected Individuals (NCT NCT00819390)

NCT ID: NCT00819390

Last Updated: 2014-10-13

Results Overview

The baseline percent CD8 HLA-DR+/CD38+ (mean of pre-entry and entry percent CD8 HLA-DR+/CD38+) was subtracted from the mean of week 10 and week 12 percent CD8 HLA-DR+/CD38+.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 70 participants
• Primary outcome timeframe: At pre-entry, entry, weeks 10 and 12
• Results posted on: 2014-10-13

Participant Flow

Version 1.0 of the study enrolled off antiretroviral therapy (ART) participants only. Off-ART participants were enrolled from March 2009 to July 2010. On-ART participants were allowed to enroll in Version 2.0 of the study. On-ART participants were enrolled from December 2010 to November 2012.

Analysis of data from off-ART and on-ART participants was done separately. The study analyses did not utilize the cross-over design, and the primary analysis consists of comparison between the chloroquine and placebo arms after the first 12 weeks on study in each off-ART and on-ART study populations.

Participant milestones

Measure	A: Chloroquine Then Placebo for Off-ART Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	B: Placebo Then Chloroquine for Off-ART Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	C: Chloroquine Then Placebo for On-ART Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	D: Placebo Then Chloroquine for On-ART Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.
Overall Study STARTED	16	17	18	19
Overall Study COMPLETED	13	16	17	19
Overall Study NOT COMPLETED	3	1	1	0

Reasons for withdrawal

Measure	A: Chloroquine Then Placebo for Off-ART Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	B: Placebo Then Chloroquine for Off-ART Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	C: Chloroquine Then Placebo for On-ART Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	D: Placebo Then Chloroquine for On-ART Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.
Overall Study Lost to Follow-up	1	1	0	0
Overall Study Withdrawal by Subject	2	0	0	0
Overall Study Adverse Event	0	0	1	0

Baseline Characteristics

Chloroquine for Reducing Immune Activation in HIV- Infected Individuals

Baseline characteristics by cohort

Measure	A: Chloroquine Then Placebo for Off-ART Participants n=16 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	B: Placebo Then Chloroquine for Off-ART Participants n=17 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	C: Chloroquine Then Placebo for On-ART Participants n=18 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	D: Placebo Then Chloroquine for On-ART Participants n=19 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	Total n=70 Participants Total of all reporting groups
Age, Continuous	35 years n=93 Participants	39 years n=4 Participants	50 years n=27 Participants	49 years n=483 Participants	46 years n=36 Participants
Age, Customized 18-29 years	5 participants n=93 Participants	2 participants n=4 Participants	1 participants n=27 Participants	0 participants n=483 Participants	8 participants n=36 Participants
Age, Customized 30-39 years	5 participants n=93 Participants	7 participants n=4 Participants	1 participants n=27 Participants	3 participants n=483 Participants	16 participants n=36 Participants
Age, Customized 40-49 years	5 participants n=93 Participants	8 participants n=4 Participants	5 participants n=27 Participants	7 participants n=483 Participants	25 participants n=36 Participants
Age, Customized 50-59 years	1 participants n=93 Participants	0 participants n=4 Participants	10 participants n=27 Participants	7 participants n=483 Participants	18 participants n=36 Participants
Age, Customized 60-69 years	0 participants n=93 Participants	0 participants n=4 Participants	0 participants n=27 Participants	2 participants n=483 Participants	2 participants n=36 Participants
Age, Customized 70-79 years	0 participants n=93 Participants	0 participants n=4 Participants	1 participants n=27 Participants	0 participants n=483 Participants	1 participants n=36 Participants
Sex: Female, Male Female	2 Participants n=93 Participants	2 Participants n=4 Participants	1 Participants n=27 Participants	2 Participants n=483 Participants	7 Participants n=36 Participants
Sex: Female, Male Male	14 Participants n=93 Participants	15 Participants n=4 Participants	17 Participants n=27 Participants	17 Participants n=483 Participants	63 Participants n=36 Participants
Region of Enrollment United States	16 participants n=93 Participants	17 participants n=4 Participants	18 participants n=27 Participants	19 participants n=483 Participants	70 participants n=36 Participants

PRIMARY outcome

Timeframe: At pre-entry, entry, weeks 10 and 12

Population: Analysis used a modified as-treated approach, limited to participants with assay data at baseline and weeks 10 or 12, and with no break in study treatment for \>=14 days. Off-ART analysis excluded participants who started ART. On-ART analysis excluded participants who stopped ART or had virologic rebound (confirmed HIV-1 RNA\>1000 copies/mL).

The baseline percent CD8 HLA-DR+/CD38+ (mean of pre-entry and entry percent CD8 HLA-DR+/CD38+) was subtracted from the mean of week 10 and week 12 percent CD8 HLA-DR+/CD38+.

Outcome measures

Measure	D: Placebo Then Chloroquine for On-ART Participants n=19 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	A: Chloroquine Then Placebo for Off-ART Participants n=15 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	B: Placebo Then Chloroquine for Off-ART Participants n=16 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	C: Chloroquine Then Placebo for On-ART Participants n=16 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.
Change in Percent CD8 HLA-DR+/CD38+ From Baseline to Week 12	-1.2 percent of CD8 expressing HLA-DR+/CD38+ Interval -3.3 to 1.4	-2.0 percent of CD8 expressing HLA-DR+/CD38+ Interval -10.0 to 9.0	-0.5 percent of CD8 expressing HLA-DR+/CD38+ Interval -2.3 to 2.8	-3.1 percent of CD8 expressing HLA-DR+/CD38+ Interval -4.3 to 0.4

SECONDARY outcome

Timeframe: For Arms A and C: Pre-entry, entry, weeks 10 and 12. For Arms B and D: Weeks 10, 12, 22 and 24

Population: Analysis used a modified as-treated approach, limited to participants with assay data at the required time points, and with no break in study treatment for \>=14 days. Off-ART analysis excluded participants who started ART. On-ART analysis excluded participants who stopped ART or had virologic rebound (confirmed HIV-1 RNA\>1000 copies/mL).

For Arm A: Chloroquine then Placebo for off-ART participants and Arm C: Chloroquine then Placebo for on-ART participants, the baseline percent CD8 HLA-DR+/CD38+ (mean of pre-entry and entry percent CD8 HLA-DR+/CD38+) was subtracted from the mean of week 10 and week 12 percent CD8 HLA-DR+/CD38+. For Arm B: Placebo then Chloroquine for off-ART participants and Arm D: Placebo then Chloroquine for on-ART participants, the mean of week 10 and week 12 percent CD8 HLA-DR+/CD38+ was subtracted from the mean of week 22 and week 24 percent CD8 HLA-DR+/CD38+.

Outcome measures

Measure	D: Placebo Then Chloroquine for On-ART Participants n=18 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	A: Chloroquine Then Placebo for Off-ART Participants n=15 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	B: Placebo Then Chloroquine for Off-ART Participants n=13 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	C: Chloroquine Then Placebo for On-ART Participants n=16 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.
Change in Percent CD8 HLA-DR+/CD38+ From Start to End of the 12-week Chloroquine Treatment Period	-2.9 percent of CD8 expressing HLA-DR+/CD38+ Interval -4.7 to -0.4	-2.0 percent of CD8 expressing HLA-DR+/CD38+ Interval -10.0 to 9.0	1.5 percent of CD8 expressing HLA-DR+/CD38+ Interval -2.5 to 7.0	-3.1 percent of CD8 expressing HLA-DR+/CD38+ Interval -4.3 to 0.4

SECONDARY outcome

Timeframe: At Weeks 10, 12, 22 and 24

Population: Analysis used a modified as-treated approach, limited to participants with assay data at weeks 10 or 12, and 22 or 24, and with no break in study treatment for \>=14 days. Off-ART analysis excluded participants who started ART. On-ART analysis excluded participants who stopped ART or had virologic rebound (confirmed HIV-1 RNA\>1000 copies/mL).

The mean of week 10 and week 12 percent CD8 HLA-DR+/CD38+ is subtracted from the mean of the week 22 and week 24 percent CD8 HLA-DR+/CD38+

Outcome measures

Measure	D: Placebo Then Chloroquine for On-ART Participants n=18 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	A: Chloroquine Then Placebo for Off-ART Participants n=12 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	B: Placebo Then Chloroquine for Off-ART Participants n=13 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	C: Chloroquine Then Placebo for On-ART Participants n=13 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.
Change in Percent CD8 HLA-DR+/CD38+ From Week 12 to Week 24	-2.9 percent of CD8 expressing HLA-DR+/CD38+ Interval -4.7 to -0.4	5.5 percent of CD8 expressing HLA-DR+/CD38+ Interval 2.0 to 13.8	1.5 percent of CD8 expressing HLA-DR+/CD38+ Interval -2.5 to 7.0	-0.1 percent of CD8 expressing HLA-DR+/CD38+ Interval -3.6 to 2.7

SECONDARY outcome

Timeframe: At Pre-entry, entry, Weeks 22 and 24

Population: Analysis used a modified as-treated approach, limited to participants with assay data at baseline and weeks 22 or 24, and with no break in study treatment for \>=14 days. Off-ART analysis excluded participants who started ART. On-ART analysis excluded participants who stopped ART or had virologic rebound (confirmed HIV-1 RNA\>1000 copies/mL).

The baseline percent CD8 HLA-DR+/CD38+ (mean of pre-entry and entry percent CD8 HLA-DR+/CD38+) was subtracted from the mean of week 22 and week 24 percent CD8 HLA-DR+/CD38+.

Outcome measures

Measure	D: Placebo Then Chloroquine for On-ART Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	A: Chloroquine Then Placebo for Off-ART Participants n=12 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	B: Placebo Then Chloroquine for Off-ART Participants n=13 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	C: Chloroquine Then Placebo for On-ART Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.
Change in Percent CD8 HLA-DR+/CD38+ From Baseline to Week 24 in Arm A and Arm C	—	10.8 percent of CD8 expressing HLA-DR+/CD38+ Interval 0.0 to 14.8	-2.4 percent of CD8 expressing HLA-DR+/CD38+ Interval -4.5 to 0.0	—

SECONDARY outcome

Timeframe: At pre-entry, entry, weeks 10 and 12

Population: Analysis used a modified as-treated approach, limited to participants with assay data at baseline and weeks 10 or 12, and with no break in study treatment for \>=14 days. Off-ART analysis excluded participants who started ART. On-ART analysis excluded participants who stopped ART or had virologic rebound (confirmed HIV-1 RNA\>1000 copies/mL).

Baseline CD4 count (mean of pre-entry and entry CD4 count) is subtracted from the mean of week 10 and week 12 CD4 count

Outcome measures

Measure	D: Placebo Then Chloroquine for On-ART Participants n=19 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	A: Chloroquine Then Placebo for Off-ART Participants n=15 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	B: Placebo Then Chloroquine for Off-ART Participants n=16 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	C: Chloroquine Then Placebo for On-ART Participants n=16 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.
Change in Total CD4 T Cell Count From Baseline to Week 12	7 cells/mm^3 Interval -17.0 to 23.0	-27 cells/mm^3 Interval -150.0 to 4.0	-11 cells/mm^3 Interval -38.0 to 71.0	-6 cells/mm^3 Interval -21.0 to 10.0

SECONDARY outcome

Timeframe: From start of study treatment to study completion at week 28

Population: Analysis is based on all enrolled participants, off-ART and on-ART, who received study treatment.

Events included signs and symptoms, laboratory abnormalities and/or clinical events grade 3 or higher which were described by site clinician blinded to the treatment arm as definitely or possibly related to the study treatment.

Outcome measures

Measure	D: Placebo Then Chloroquine for On-ART Participants n=19 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	A: Chloroquine Then Placebo for Off-ART Participants n=16 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	B: Placebo Then Chloroquine for Off-ART Participants n=17 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	C: Chloroquine Then Placebo for On-ART Participants n=18 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.
Number of Participants With Events Grade 3 or Higher	0 participants	0 participants	1 participants	1 participants

SECONDARY outcome

Timeframe: At Entry

Population: Analysis is based on all off-ART participants with HIV-1 RNA data at entry.

Results reported are for HIV-1 RNA (copies/mL) at study entry for off-ART participants.

Outcome measures

Measure	D: Placebo Then Chloroquine for On-ART Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	A: Chloroquine Then Placebo for Off-ART Participants n=16 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	B: Placebo Then Chloroquine for Off-ART Participants n=17 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	C: Chloroquine Then Placebo for On-ART Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.
HIV-1 RNA Copies/mL at Study Entry for Off-ART Participants	—	4.48 log10 copies/mL Interval 4.02 to 4.74	4.42 log10 copies/mL Interval 4.03 to 4.83	—

SECONDARY outcome

Timeframe: At weeks 12 and 24

Population: Analysis is based on all off-ART participants with HIV-1 RNA data at week 12 and week 24.

Results reported are for HIV-1 RNA (copies/mL) at week 12 and week 24 for off-ART participants.

Outcome measures

Measure	D: Placebo Then Chloroquine for On-ART Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	A: Chloroquine Then Placebo for Off-ART Participants n=14 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	B: Placebo Then Chloroquine for Off-ART Participants n=16 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	C: Chloroquine Then Placebo for On-ART Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.
HIV-1 RNA Copies/mL at Weeks 12 and 24 for Off-ART Participants Week 12	—	4.68 log10 copies/mL Interval 4.46 to 4.79	4.28 log10 copies/mL Interval 4.08 to 4.6	—
HIV-1 RNA Copies/mL at Weeks 12 and 24 for Off-ART Participants Week 24	—	4.69 log10 copies/mL Interval 4.31 to 4.9	4.61 log10 copies/mL Interval 4.45 to 4.87	—

SECONDARY outcome

Timeframe: At Entry

Population: Analysis is based on all on-ART participants with HIV-1 RNA data at entry.

Results reported are for HIV-1 RNA at study entry for on-ART participants.

Outcome measures

Measure	D: Placebo Then Chloroquine for On-ART Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	A: Chloroquine Then Placebo for Off-ART Participants n=18 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	B: Placebo Then Chloroquine for Off-ART Participants n=19 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	C: Chloroquine Then Placebo for On-ART Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.
HIV-1 RNA Copies/mL at Study Entry for On-ART Participants at or below lower limit of quantitation	—	16 participants	17 participants	—
HIV-1 RNA Copies/mL at Study Entry for On-ART Participants above lower limit of quantitation	—	2 participants	2 participants	—

SECONDARY outcome

Timeframe: At week 12

Population: Analysis is based on all on-ART participants with HIV-1 RNA data at week 12.

Results reported are for HIV-1 RNA at week 12 for on-ART participants.

Outcome measures

Measure	D: Placebo Then Chloroquine for On-ART Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	A: Chloroquine Then Placebo for Off-ART Participants n=17 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	B: Placebo Then Chloroquine for Off-ART Participants n=19 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	C: Chloroquine Then Placebo for On-ART Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.
HIV-1 RNA Copies/mL at Week 12 for On-ART Participants at or below lower limit of quantitation	—	16 participants	18 participants	—
HIV-1 RNA Copies/mL at Week 12 for On-ART Participants above lower limit of quantitation	—	1 participants	1 participants	—

SECONDARY outcome

Timeframe: At week 24

Population: Analysis is based on all on-ART participants with HIV-1 RNA data at week 24.

Results reported are for HIV-1 RNA at week 24 for on-ART participants.

Outcome measures

Measure	D: Placebo Then Chloroquine for On-ART Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	A: Chloroquine Then Placebo for Off-ART Participants n=16 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	B: Placebo Then Chloroquine for Off-ART Participants n=19 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	C: Chloroquine Then Placebo for On-ART Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.
HIV-1 RNA Copies/mL at Week 24 for On-ART Participants at or below lower limit of quantitation	—	14 participants	18 participants	—
HIV-1 RNA Copies/mL at Week 24 for On-ART Participants above lower limit of quantitation	—	2 participants	1 participants	—

SECONDARY outcome

Timeframe: At pre-entry and entry

Population: Analysis is based on all participants with assay data at pre-entry or entry.

Baseline CD8 CD38+ is computed as the mean of pre-entry and entry CD8 CD38+.

Outcome measures

Measure	D: Placebo Then Chloroquine for On-ART Participants n=19 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	A: Chloroquine Then Placebo for Off-ART Participants n=15 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	B: Placebo Then Chloroquine for Off-ART Participants n=16 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	C: Chloroquine Then Placebo for On-ART Participants n=17 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.
Percent CD8 CD38+ at Baseline	49.9 percent of CD8 expressing CD38+ Interval 37.8 to 63.5	71.0 percent of CD8 expressing CD38+ Interval 66.0 to 80.5	77.0 percent of CD8 expressing CD38+ Interval 71.5 to 88.3	50.8 percent of CD8 expressing CD38+ Interval 40.1 to 65.6

SECONDARY outcome

Timeframe: At Week 12

Population: Analysis is based on all participants with assay data at week 12.

Results reported are the week 12 percentage of CD8 expressing CD38+.

Outcome measures

Measure	D: Placebo Then Chloroquine for On-ART Participants n=19 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	A: Chloroquine Then Placebo for Off-ART Participants n=14 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	B: Placebo Then Chloroquine for Off-ART Participants n=16 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	C: Chloroquine Then Placebo for On-ART Participants n=16 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.
Percent CD8 CD38+ at Week 12	51.9 percent of CD8 expressing CD38+ Interval 38.7 to 63.0	71.5 percent of CD8 expressing CD38+ Interval 67.0 to 83.0	79.5 percent of CD8 expressing CD38+ Interval 69.0 to 88.5	50.9 percent of CD8 expressing CD38+ Interval 37.2 to 63.6

SECONDARY outcome

Timeframe: At Week 24

Population: Analysis is based on all participants with assay data at week 24.

Results reported are the week 24 percentage of CD8 expressing CD38+.

Outcome measures

Measure	D: Placebo Then Chloroquine for On-ART Participants n=19 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	A: Chloroquine Then Placebo for Off-ART Participants n=13 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	B: Placebo Then Chloroquine for Off-ART Participants n=14 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	C: Chloroquine Then Placebo for On-ART Participants n=16 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.
Percent CD8 CD38+ at Week 24	48.7 percent of CD8 expressing CD38+ Interval 38.2 to 64.9	78.0 percent of CD8 expressing CD38+ Interval 74.0 to 86.0	79.5 percent of CD8 expressing CD38+ Interval 69.0 to 89.0	50.6 percent of CD8 expressing CD38+ Interval 40.6 to 54.4

SECONDARY outcome

Timeframe: At pre-entry and entry

Population: Analysis is based on all participants with assay data at pre-entry or entry.

Baseline CD4 HLA-DR+/CD38+ is computed as the mean of pre-entry and entry CD4 HLA-DR+/CD38+.

Outcome measures

Measure	D: Placebo Then Chloroquine for On-ART Participants n=19 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	A: Chloroquine Then Placebo for Off-ART Participants n=15 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	B: Placebo Then Chloroquine for Off-ART Participants n=16 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	C: Chloroquine Then Placebo for On-ART Participants n=17 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.
Percent CD4 HLA-DR+/CD38+ at Baseline	9.9 percent of CD4 expressing HLA-DR+/CD38+ Interval 6.8 to 12.3	8.5 percent of CD4 expressing HLA-DR+/CD38+ Interval 5.5 to 12.0	9.8 percent of CD4 expressing HLA-DR+/CD38+ Interval 8.8 to 14.3	8.7 percent of CD4 expressing HLA-DR+/CD38+ Interval 6.9 to 10.0

SECONDARY outcome

Timeframe: At Week 12

Population: Analysis is based on all participants with assay data at week 12.

Results reported are the week 12 percentage of CD4 expressing HLA-DR+/CD38+.

Outcome measures

Measure	D: Placebo Then Chloroquine for On-ART Participants n=19 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	A: Chloroquine Then Placebo for Off-ART Participants n=14 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	B: Placebo Then Chloroquine for Off-ART Participants n=16 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	C: Chloroquine Then Placebo for On-ART Participants n=16 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.
Percent CD4 HLA-DR+/CD38+ at Week 12	9.0 percent of CD4 expressing HLA-DR+/CD38+ Interval 7.0 to 14.0	6.5 percent of CD4 expressing HLA-DR+/CD38+ Interval 4.0 to 13.0	10.5 percent of CD4 expressing HLA-DR+/CD38+ Interval 8.0 to 14.0	7.7 percent of CD4 expressing HLA-DR+/CD38+ Interval 4.2 to 9.2

SECONDARY outcome

Timeframe: At Week 24

Population: Analysis is based on all participants with assay data at week 24.

Results reported are the week 24 percentage of CD4 expressing HLA-DR+/CD38+.

Outcome measures

Measure	D: Placebo Then Chloroquine for On-ART Participants n=19 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	A: Chloroquine Then Placebo for Off-ART Participants n=13 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	B: Placebo Then Chloroquine for Off-ART Participants n=14 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	C: Chloroquine Then Placebo for On-ART Participants n=16 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.
Percent CD4 HLA-DR+/CD38+ at Week 24	9.2 percent of CD4 expressing HLA-DR+/CD38+ Interval 7.8 to 13.4	11.0 percent of CD4 expressing HLA-DR+/CD38+ Interval 6.0 to 14.0	12.5 percent of CD4 expressing HLA-DR+/CD38+ Interval 8.0 to 18.0	7.3 percent of CD4 expressing HLA-DR+/CD38+ Interval 6.0 to 8.5

SECONDARY outcome

Timeframe: At pre-entry and entry

Population: Analysis is based on all participants with assay data at pre-entry or entry.

Baseline IL-6, sTNF-rI and D-dimer were computed as the mean of pre-entry and entry IL-6, sTNF-rI and D-dimer, respectively.

Outcome measures

Measure	D: Placebo Then Chloroquine for On-ART Participants n=19 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	A: Chloroquine Then Placebo for Off-ART Participants n=15 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	B: Placebo Then Chloroquine for Off-ART Participants n=16 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	C: Chloroquine Then Placebo for On-ART Participants n=17 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.
IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Baseline IL-6	1.51 pg/mL Interval 1.01 to 1.92	1.65 pg/mL Interval 0.77 to 2.66	1.62 pg/mL Interval 0.97 to 1.97	1.01 pg/mL Interval 0.72 to 1.56
IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Baseline sTNF-rI	1250.85 pg/mL Interval 995.6 to 1591.8	1228.66 pg/mL Interval 992.52 to 1359.06	1377.81 pg/mL Interval 1086.72 to 1558.35	1316.63 pg/mL Interval 1127.96 to 1487.45
IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Baseline D-dimer	103530 pg/mL Interval 71420.0 to 193330.0	286390 pg/mL Interval 162780.0 to 541950.0	328460 pg/mL Interval 188690.0 to 422650.0	107890 pg/mL Interval 88440.0 to 151810.0

SECONDARY outcome

Timeframe: At week 12

Population: Analysis is based on all participants with assay data at week 12.

Results reported are the week 12 IL-6, sTNF-rI and D-dimer.

Outcome measures

Measure	D: Placebo Then Chloroquine for On-ART Participants n=18 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	A: Chloroquine Then Placebo for Off-ART Participants n=13 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	B: Placebo Then Chloroquine for Off-ART Participants n=16 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	C: Chloroquine Then Placebo for On-ART Participants n=15 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.
IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Week 12 sTNF-rI	1304.77 pg/mL Interval 1092.7 to 1473.54	1209.50 pg/mL Interval 1027.01 to 1385.7	1347.06 pg/mL Interval 1242.37 to 1538.05	1441.35 pg/mL Interval 1149.16 to 1711.86
IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Week 12 D-dimer	117890 pg/mL Interval 73540.0 to 207890.0	251320 pg/mL Interval 161660.0 to 621030.0	319770 pg/mL Interval 189170.0 to 582040.0	126540 pg/mL Interval 102190.0 to 179220.0
IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Week 12 IL-6	1.30 pg/mL Interval 1.06 to 2.31	1.68 pg/mL Interval 0.96 to 2.35	1.28 pg/mL Interval 0.96 to 2.79	1.15 pg/mL Interval 0.79 to 2.07

SECONDARY outcome

Timeframe: At week 24

Population: Analysis is based on all participants with assay data at week 24.

Results reported are the week 24 IL-6, sTNF-rI and D-dimer.

Outcome measures

Measure	D: Placebo Then Chloroquine for On-ART Participants n=19 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	A: Chloroquine Then Placebo for Off-ART Participants n=14 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	B: Placebo Then Chloroquine for Off-ART Participants n=16 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	C: Chloroquine Then Placebo for On-ART Participants n=16 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.
IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Week 24 sTNF-rI	1176.20 pg/mL Interval 1060.28 to 1629.53	1327.21 pg/mL Interval 1056.79 to 1602.16	1420.30 pg/mL Interval 1229.57 to 1600.32	1230.21 pg/mL Interval 1063.46 to 1358.3
IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Week 24 D-dimer	124920 pg/mL Interval 83130.0 to 182450.0	264240 pg/mL Interval 210110.0 to 380880.0	294780 pg/mL Interval 215400.0 to 615550.0	100860 pg/mL Interval 78400.0 to 128350.0
IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Week 24 IL-6	1.27 pg/mL Interval 1.01 to 2.33	1.34 pg/mL Interval 1.1 to 2.34	1.18 pg/mL Interval 0.84 to 2.74	1.02 pg/mL Interval 0.8 to 1.45

SECONDARY outcome

Timeframe: At pre-entry and entry

Population: Analysis is based on all participants with assay data at pre-entry or entry.

Baseline sCD14 was computed as the mean of pre-entry and entry sCD14.

Outcome measures

Measure	D: Placebo Then Chloroquine for On-ART Participants n=19 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	A: Chloroquine Then Placebo for Off-ART Participants n=15 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	B: Placebo Then Chloroquine for Off-ART Participants n=16 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	C: Chloroquine Then Placebo for On-ART Participants n=17 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.
Soluble CD14 (sCD14) at Baseline	1.58 million pg/mL Interval 1.39 to 1.87	1.43 million pg/mL Interval 1.23 to 1.79	1.97 million pg/mL Interval 1.77 to 2.27	1.80 million pg/mL Interval 1.65 to 2.18

SECONDARY outcome

Timeframe: At week 12

Population: Analysis is based on all participants with assay data at week 12.

Results reported are the week 12 sCD14.

Outcome measures

Measure	D: Placebo Then Chloroquine for On-ART Participants n=18 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	A: Chloroquine Then Placebo for Off-ART Participants n=13 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	B: Placebo Then Chloroquine for Off-ART Participants n=16 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	C: Chloroquine Then Placebo for On-ART Participants n=15 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.
Soluble CD14 (sCD14) at Week 12	1.63 million pg/mL Interval 1.35 to 1.82	1.53 million pg/mL Interval 1.39 to 2.05	1.88 million pg/mL Interval 1.64 to 2.3	2.04 million pg/mL Interval 1.6 to 2.21

SECONDARY outcome

Timeframe: At week 24

Population: Analysis is based on all participants with assay data at week 24.

Results reported are the week 24 sCD14.

Outcome measures

Measure	D: Placebo Then Chloroquine for On-ART Participants n=19 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	A: Chloroquine Then Placebo for Off-ART Participants n=14 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	B: Placebo Then Chloroquine for Off-ART Participants n=16 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	C: Chloroquine Then Placebo for On-ART Participants n=16 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.
Soluble CD14 (sCD14) at Week 24	1.72 million pg/mL Interval 1.54 to 2.15	1.53 million pg/mL Interval 1.37 to 1.97	2.19 million pg/mL Interval 1.79 to 2.35	1.77 million pg/mL Interval 1.49 to 2.39

SECONDARY outcome

Timeframe: At entry

Population: Analysis is based on all participants with assay data at entry.

Results reported are for entry fasting LPS.

Outcome measures

Measure	D: Placebo Then Chloroquine for On-ART Participants n=19 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	A: Chloroquine Then Placebo for Off-ART Participants n=15 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	B: Placebo Then Chloroquine for Off-ART Participants n=16 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	C: Chloroquine Then Placebo for On-ART Participants n=17 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.
Fasting Lipopolysaccharides (LPS) at Entry	7.00 pg/mL Interval 2.0 to 8.0	13.68 pg/mL Interval 3.79 to 31.38	1.64 pg/mL Interval 0.7 to 28.98	8.00 pg/mL Interval 6.0 to 10.0

SECONDARY outcome

Timeframe: At week 12

Population: Analysis is based on all participants with assay data at week 12.

Results reported are the week 12 fasting LPS.

Outcome measures

Measure	D: Placebo Then Chloroquine for On-ART Participants n=18 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	A: Chloroquine Then Placebo for Off-ART Participants n=14 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	B: Placebo Then Chloroquine for Off-ART Participants n=16 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	C: Chloroquine Then Placebo for On-ART Participants n=15 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.
Fasting Lipopolysaccharides (LPS) at Week 12	7.00 pg/mL Interval 4.0 to 9.0	14.37 pg/mL Interval 4.26 to 36.63	13.06 pg/mL Interval 0.7 to 36.58	7.00 pg/mL Interval 6.0 to 9.0

SECONDARY outcome

Timeframe: At week 24

Population: Analysis is based on all participants with assay data at week 24.

Results reported are the week 24 fasting LPS.

Outcome measures

Measure	D: Placebo Then Chloroquine for On-ART Participants n=19 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	A: Chloroquine Then Placebo for Off-ART Participants n=14 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	B: Placebo Then Chloroquine for Off-ART Participants n=16 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	C: Chloroquine Then Placebo for On-ART Participants n=16 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.
Fasting Lipopolysaccharides (LPS) at Week 24	8.00 pg/mL Interval 6.0 to 10.0	20.54 pg/mL Interval 7.56 to 37.8	2.83 pg/mL Interval 0.7 to 30.57	7.00 pg/mL Interval 6.0 to 9.0

SECONDARY outcome

Timeframe: At pre-entry and entry

Population: Analysis is based on all participants with assay data at pre-entry or entry.

Baseline percent activation levels of pDC were computed as the mean of pre-entry and entry percent activation levels of pDC. Similarly, baseline percent activation levels of mDC were computed as the mean of pre-entry and entry percent activation levels of mDC.

Outcome measures

Measure	D: Placebo Then Chloroquine for On-ART Participants n=19 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	A: Chloroquine Then Placebo for Off-ART Participants n=16 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	B: Placebo Then Chloroquine for Off-ART Participants n=17 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	C: Chloroquine Then Placebo for On-ART Participants n=18 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.
Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Baseline %pDC expressing CD80+	0.07 percentage of cells Interval 0.05 to 0.2	0.03 percentage of cells Interval 0.0 to 0.1	0.03 percentage of cells Interval 0.0 to 0.07	0.13 percentage of cells Interval 0.07 to 0.18
Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Baseline %pDC expressing CD83+	23.65 percentage of cells Interval 7.49 to 27.99	45.48 percentage of cells Interval 28.93 to 59.4	36.15 percentage of cells Interval 27.18 to 52.28	19.91 percentage of cells Interval 13.98 to 26.58
Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Baseline %pDC expressing CD86+	12.66 percentage of cells Interval 8.28 to 17.91	9.12 percentage of cells Interval 7.01 to 10.79	9.35 percentage of cells Interval 6.33 to 11.65	10.96 percentage of cells Interval 5.9 to 14.04
Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Baseline %pDC expressing PDL-1+	6.49 percentage of cells Interval 2.48 to 12.03	2.52 percentage of cells Interval 2.0 to 6.16	6.13 percentage of cells Interval 3.01 to 12.99	4.48 percentage of cells Interval 2.53 to 8.36
Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Baseline %mDC expressing CD80+	1.17 percentage of cells Interval 0.76 to 2.3	1.04 percentage of cells Interval 0.45 to 1.49	0.83 percentage of cells Interval 0.47 to 1.01	1.31 percentage of cells Interval 0.73 to 1.62
Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Baseline %mDC expressing CD83+	26.08 percentage of cells Interval 12.46 to 53.69	38.60 percentage of cells Interval 9.51 to 55.88	39.94 percentage of cells Interval 21.98 to 59.07	48.17 percentage of cells Interval 35.51 to 65.88
Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Baseline %mDC expressing CD86+	95.38 percentage of cells Interval 90.57 to 96.69	96.29 percentage of cells Interval 94.13 to 98.55	97.52 percentage of cells Interval 95.69 to 98.5	96.11 percentage of cells Interval 94.31 to 98.3
Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Baseline %mDC expressing PDL-1+	8.28 percentage of cells Interval 3.08 to 11.5	9.82 percentage of cells Interval 6.32 to 13.54	16.37 percentage of cells Interval 7.76 to 30.19	4.58 percentage of cells Interval 2.71 to 7.93

SECONDARY outcome

Timeframe: At week 12

Population: Analysis is based on all participants with assay data at week 12.

Results reported are the week 12 percent activation levels of pDC and mDC.

Outcome measures

Measure	D: Placebo Then Chloroquine for On-ART Participants n=19 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	A: Chloroquine Then Placebo for Off-ART Participants n=13 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	B: Placebo Then Chloroquine for Off-ART Participants n=16 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	C: Chloroquine Then Placebo for On-ART Participants n=17 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.
Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 12 %pDC expressing CD80+	0.14 percentage of cells Interval 0.0 to 0.4	0.00 percentage of cells Interval 0.0 to 0.03	0.05 percentage of cells Interval 0.0 to 0.15	0.10 percentage of cells Interval 0.0 to 0.2
Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 12 %pDC expressing CD83+	18.20 percentage of cells Interval 8.08 to 32.3	51.90 percentage of cells Interval 22.6 to 55.6	40.49 percentage of cells Interval 30.35 to 47.9	14.70 percentage of cells Interval 8.28 to 24.77
Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 12 %pDC expressing CD86+	13.64 percentage of cells Interval 8.63 to 18.09	7.66 percentage of cells Interval 6.5 to 8.52	8.48 percentage of cells Interval 5.26 to 12.22	13.93 percentage of cells Interval 6.55 to 17.84
Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 12 %pDC expressing PDL-1+	5.16 percentage of cells Interval 2.8 to 12.72	3.74 percentage of cells Interval 2.66 to 5.98	8.43 percentage of cells Interval 3.27 to 16.53	7.24 percentage of cells Interval 2.24 to 10.67
Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 12 %mDC expressing CD80+	1.01 percentage of cells Interval 0.9 to 2.28	0.84 percentage of cells Interval 0.59 to 1.12	1.03 percentage of cells Interval 0.68 to 1.71	1.47 percentage of cells Interval 0.95 to 1.87
Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 12 %mDC expressing CD86+	95.15 percentage of cells Interval 87.18 to 96.38	97.90 percentage of cells Interval 96.99 to 98.51	97.18 percentage of cells Interval 96.3 to 98.65	95.40 percentage of cells Interval 91.26 to 97.2
Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 12 %mDC expressing PDL-1+	6.09 percentage of cells Interval 2.69 to 15.81	15.03 percentage of cells Interval 9.12 to 17.48	16.32 percentage of cells Interval 9.49 to 36.81	7.10 percentage of cells Interval 3.18 to 10.56
Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 12 %mDC expressing CD83+	26.75 percentage of cells Interval 13.6 to 51.4	43.51 percentage of cells Interval 20.34 to 51.74	36.47 percentage of cells Interval 27.54 to 46.41	47.83 percentage of cells Interval 32.32 to 65.29

SECONDARY outcome

Timeframe: At week 24

Population: Analysis is based on all participants with assay data at week 24.

Results reported are the week 24 percent activation levels of pDC and mDC.

Outcome measures

Measure	D: Placebo Then Chloroquine for On-ART Participants n=18 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	A: Chloroquine Then Placebo for Off-ART Participants n=14 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	B: Placebo Then Chloroquine for Off-ART Participants n=16 Participants Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	C: Chloroquine Then Placebo for On-ART Participants n=16 Participants Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.
Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 24 %pDC expressing CD80+	0.16 percentage of cells Interval 0.05 to 0.23	0.05 percentage of cells Interval 0.0 to 0.08	0.00 percentage of cells Interval 0.0 to 0.05	0.08 percentage of cells Interval 0.03 to 0.18
Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 24 %pDC expressing CD83+	17.65 percentage of cells Interval 7.78 to 21.44	44.50 percentage of cells Interval 26.6 to 60.3	38.96 percentage of cells Interval 23.17 to 45.51	14.80 percentage of cells Interval 7.9 to 25.62
Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 24 %pDC expressing CD86+	12.88 percentage of cells Interval 8.99 to 19.21	10.13 percentage of cells Interval 7.12 to 10.73	7.89 percentage of cells Interval 4.86 to 12.61	11.79 percentage of cells Interval 6.81 to 20.98
Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 24 %pDC expressing PDL-1+	6.52 percentage of cells Interval 1.05 to 12.69	4.34 percentage of cells Interval 1.7 to 8.08	7.45 percentage of cells Interval 2.83 to 15.09	5.63 percentage of cells Interval 2.53 to 10.83
Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 24 %mDC expressing CD80+	1.39 percentage of cells Interval 0.89 to 2.0	0.94 percentage of cells Interval 0.36 to 1.28	1.12 percentage of cells Interval 0.67 to 1.34	0.76 percentage of cells Interval 0.65 to 1.38
Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 24 %mDC expressing CD83+	24.14 percentage of cells Interval 12.93 to 36.67	41.21 percentage of cells Interval 25.74 to 49.61	33.19 percentage of cells Interval 24.04 to 47.68	36.65 percentage of cells Interval 22.35 to 52.38
Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 24 %mDC expressing CD86+	92.41 percentage of cells Interval 89.01 to 97.2	97.70 percentage of cells Interval 95.8 to 99.04	97.05 percentage of cells Interval 95.4 to 98.31	96.69 percentage of cells Interval 92.46 to 97.89
Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 24 %mDC expressing PDL-1+	7.49 percentage of cells Interval 3.15 to 13.64	9.53 percentage of cells Interval 6.31 to 18.85	14.84 percentage of cells Interval 11.11 to 40.45	4.13 percentage of cells Interval 2.14 to 11.82

Adverse Events

A: Chloroquine Then Placebo for Off-ART Participants

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

B: Placebo Then Chloroquine for Off-ART Participants

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

C: Chloroquine Then Placebo for On-ART Participants

Serious events: 3 serious events

Other events: 10 other events

Deaths: 0 deaths

D: Placebo Then Chloroquine for On-ART Participants

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	A: Chloroquine Then Placebo for Off-ART Participants n=16 participants at risk Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	B: Placebo Then Chloroquine for Off-ART Participants n=17 participants at risk Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	C: Chloroquine Then Placebo for On-ART Participants n=18 participants at risk Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	D: Placebo Then Chloroquine for On-ART Participants n=19 participants at risk Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.
Gastrointestinal disorders Abdominal pain	6.2% 1/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Infections and infestations Pneumonia	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.6% 1/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Nervous system disorders Cerebrovascular accident	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.6% 1/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Psychiatric disorders Abnormal behaviour	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.6% 1/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Psychiatric disorders Suicidal ideation	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.9% 1/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Psychiatric disorders Suicide attempt	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.3% 1/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.3% 1/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).

Other adverse events

Measure	A: Chloroquine Then Placebo for Off-ART Participants n=16 participants at risk Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	B: Placebo Then Chloroquine for Off-ART Participants n=17 participants at risk Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	C: Chloroquine Then Placebo for On-ART Participants n=18 participants at risk Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.	D: Placebo Then Chloroquine for On-ART Participants n=19 participants at risk Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit. Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks. Placebo: Taken orally, once daily for 12 weeks.
General disorders Chest discomfort	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.6% 1/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
General disorders Chest pain	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.6% 1/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.3% 1/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.9% 1/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Ear and labyrinth disorders Ear pain	6.2% 1/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.6% 1/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Ear and labyrinth disorders Tinnitus	6.2% 1/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Endocrine disorders Hypothyroidism	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.3% 1/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Eye disorders Blepharitis	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.9% 1/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Eye disorders Dry eye	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.9% 1/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Eye disorders Eye pain	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.6% 1/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Eye disorders Oculogyric crisis	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.6% 1/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Eye disorders Retinal depigmentation	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.6% 1/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Eye disorders Retinal pigmentation	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.6% 1/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Eye disorders Vision blurred	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.9% 1/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.6% 1/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Eye disorders Visual impairment	12.5% 2/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Gastrointestinal disorders Anogenital dysplasia	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.6% 1/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.3% 1/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Infections and infestations Acute hepatitis C	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.9% 1/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Infections and infestations Bacterial infection	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.9% 1/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Infections and infestations Conjunctivitis	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.9% 1/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Infections and infestations Genitourinary chlamydia infection	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.9% 1/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Infections and infestations Hepatitis C	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.9% 1/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Infections and infestations Herpes simplex	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.9% 1/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Infections and infestations Latent syphilis	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.3% 1/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Infections and infestations Oesophageal candidiasis	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.9% 1/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Infections and infestations Onychomycosis	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.3% 1/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Infections and infestations Oropharyngeal candidiasis	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.9% 1/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Infections and infestations Otitis media	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.3% 1/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Infections and infestations Pharyngitis	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.9% 1/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Infections and infestations Pneumonia bacterial	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.6% 1/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Infections and infestations Secondary syphilis	6.2% 1/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Infections and infestations Tinea pedis	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.3% 1/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Infections and infestations Upper respiratory tract infection	6.2% 1/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.3% 1/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Infections and infestations Vulvovaginitis trichomonal	6.2% 1/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Injury, poisoning and procedural complications Ankle fracture	6.2% 1/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Injury, poisoning and procedural complications Overdose	6.2% 1/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Investigations Alanine aminotransferase increased	12.5% 2/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.9% 1/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.6% 1/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Investigations Aspartate aminotransferase increased	12.5% 2/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	17.6% 3/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.6% 1/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Investigations Blood albumin abnormal	6.2% 1/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	11.8% 2/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Investigations Blood alkaline phosphatase abnormal	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.3% 1/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Investigations Blood alkaline phosphatase increased	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.6% 1/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.3% 1/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Investigations Blood bilirubin increased	6.2% 1/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.9% 1/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.6% 1/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.3% 1/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Investigations Blood cholesterol	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.6% 1/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Investigations Blood creatinine increased	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.9% 1/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Investigations Blood glucose abnormal	12.5% 2/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	11.8% 2/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Investigations Blood glucose increased	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.6% 1/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.3% 1/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Investigations Blood phosphorus decreased	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.6% 1/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Investigations Blood potassium decreased	6.2% 1/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Investigations Blood potassium increased	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.6% 1/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Investigations Blood sodium decreased	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.9% 1/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Investigations Neutrophil count decreased	6.2% 1/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.9% 1/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.6% 1/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Investigations Platelet count decreased	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.6% 1/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Metabolism and nutrition disorders Decreased appetite	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.6% 1/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.9% 1/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.6% 1/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anorectal human papilloma virus infection	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.6% 1/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	6.2% 1/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibrous histiocytoma	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.6% 1/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Penile wart	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.6% 1/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.6% 1/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.6% 1/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Nervous system disorders Balance disorder	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.6% 1/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Nervous system disorders Dizziness	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.9% 1/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.6% 1/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Nervous system disorders Headache	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	11.1% 2/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Psychiatric disorders Acute psychosis	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.6% 1/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Psychiatric disorders Agitation	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.6% 1/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Psychiatric disorders Anxiety	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.6% 1/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Psychiatric disorders Confusional state	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.6% 1/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Psychiatric disorders Dependence	6.2% 1/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Psychiatric disorders Depressed mood	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.6% 1/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Psychiatric disorders Hallucination, auditory	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.9% 1/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Psychiatric disorders Hallucination, visual	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.6% 1/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Psychiatric disorders Insomnia	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.6% 1/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Psychiatric disorders Paranoia	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.6% 1/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Psychiatric disorders Suicidal ideation	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.3% 1/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Reproductive system and breast disorders Scrotal varicose veins	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.6% 1/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.3% 1/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.9% 1/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.6% 1/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.6% 1/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.6% 1/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.6% 1/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Skin and subcutaneous tissue disorders Dermatosis	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.3% 1/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Social circumstances Poor personal hygiene	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.6% 1/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Vascular disorders Hypertension	0.00% 0/16 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.9% 1/17 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	0.00% 0/18 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).	5.3% 1/19 • AEs reported from start of study treatment until study completion at 28 weeks. AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).

Additional Information

ACTG Clinicaltrials.gov Coordinator

ACTG Network Coordinating Center, Social and Scientific Systems

Phone: (301) 628-3313

Email: ACTGCT.Gov@s-3.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place