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Chloroquine for Reducing Immune Activation in HIV- Infected Individuals

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00819390
Recruitment Status : Completed
First Posted : January 9, 2009
Results First Posted : September 5, 2014
Last Update Posted : October 13, 2014
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
AIDS Clinical Trials Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: Chloroquine
Drug: Placebo
Enrollment 70
Recruitment Details

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.

Pre-assignment Details 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.
Arm/Group Title A: Chloroquine Then Placebo for Off-ART Participants B: Placebo Then Chloroquine for Off-ART Participants C: Chloroquine Then Placebo for On-ART Participants D: Placebo Then Chloroquine for On-ART Participants
Hide Arm/Group Description

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.

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.

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.

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.

Period Title: Overall Study
Started 16 17 18 19
Completed 13 16 17 19
Not Completed 3 1 1 0
Reason Not Completed
Lost to Follow-up             1             1             0             0
Withdrawal by Subject             2             0             0             0
Adverse Event             0             0             1             0
Arm/Group Title A: Chloroquine Then Placebo for Off-ART Participants B: Placebo Then Chloroquine for Off-ART Participants C: Chloroquine Then Placebo for On-ART Participants D: Placebo Then Chloroquine for On-ART Participants Total
Hide Arm/Group Description

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.

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.

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.

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 of all reporting groups
Overall Number of Baseline Participants 16 17 18 19 70
Hide Baseline Analysis Population Description
Results are for all participants, off-ART and on-ART, who enrolled in the study.
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 16 participants 17 participants 18 participants 19 participants 70 participants
35
(29 to 43)
39
(35 to 44)
50
(48 to 55)
49
(41 to 56)
46
(36 to 50)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 16 participants 17 participants 18 participants 19 participants 70 participants
18-29 years 5 2 1 0 8
30-39 years 5 7 1 3 16
40-49 years 5 8 5 7 25
50-59 years 1 0 10 7 18
60-69 years 0 0 0 2 2
70-79 years 0 0 1 0 1
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 17 participants 18 participants 19 participants 70 participants
Female
2
  12.5%
2
  11.8%
1
   5.6%
2
  10.5%
7
  10.0%
Male
14
  87.5%
15
  88.2%
17
  94.4%
17
  89.5%
63
  90.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants 17 participants 18 participants 19 participants 70 participants
16 17 18 19 70
1.Primary Outcome
Title Change in Percent CD8 HLA-DR+/CD38+ From Baseline to Week 12
Hide Description 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+.
Time Frame At pre-entry, entry, weeks 10 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title A: Chloroquine Then Placebo for Off-ART Participants B: Placebo Then Chloroquine for Off-ART Participants C: Chloroquine Then Placebo for On-ART Participants D: Placebo Then Chloroquine for On-ART Participants
Hide Arm/Group Description:

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.

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.

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.

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 Number of Participants Analyzed 15 16 16 19
Median (Inter-Quartile Range)
Unit of Measure: percent of CD8 expressing HLA-DR+/CD38+
-2.0
(-10.0 to 9.0)
-0.5
(-2.3 to 2.8)
-3.1
(-4.3 to 0.4)
-1.2
(-3.3 to 1.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A: Chloroquine Then Placebo for Off-ART Participants, B: Placebo Then Chloroquine for Off-ART Participants
Comments Null hypothesis: There is no difference between the two arms/groups with respect to change in percent CD8 HLA-DR+/CD38+ from baseline to week 12.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.428
Comments The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05.
Method Wilcoxon (Mann-Whitney)
Comments No other adjustments
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection C: Chloroquine Then Placebo for On-ART Participants, D: Placebo Then Chloroquine for On-ART Participants
Comments Null hypothesis: There is no difference between the two arms/groups with respect to change in percent CD8 HLA-DR+/CD38+ from baseline to week 12.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.247
Comments The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05.
Method Wilcoxon (Mann-Whitney)
Comments No other adjustments.
2.Secondary Outcome
Title Change in Percent CD8 HLA-DR+/CD38+ From Start to End of the 12-week Chloroquine Treatment Period
Hide Description 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+.
Time Frame For Arms A and C: Pre-entry, entry, weeks 10 and 12. For Arms B and D: Weeks 10, 12, 22 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title A: Chloroquine Then Placebo for Off-ART Participants B: Placebo Then Chloroquine for Off-ART Participants C: Chloroquine Then Placebo for On-ART Participants D: Placebo Then Chloroquine for On-ART Participants
Hide Arm/Group Description:

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.

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.

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.

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 Number of Participants Analyzed 15 13 16 18
Median (Inter-Quartile Range)
Unit of Measure: percent of CD8 expressing HLA-DR+/CD38+
-2.0
(-10.0 to 9.0)
1.5
(-2.5 to 7.0)
-3.1
(-4.3 to 0.4)
-2.9
(-4.7 to -0.4)
3.Secondary Outcome
Title Change in Percent CD8 HLA-DR+/CD38+ From Week 12 to Week 24
Hide Description 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+
Time Frame At Weeks 10, 12, 22 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title A: Chloroquine Then Placebo for Off-ART Participants B: Placebo Then Chloroquine for Off-ART Participants C: Chloroquine Then Placebo for On-ART Participants D: Placebo Then Chloroquine for On-ART Participants
Hide Arm/Group Description:

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.

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.

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.

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 Number of Participants Analyzed 12 13 13 18
Median (Inter-Quartile Range)
Unit of Measure: percent of CD8 expressing HLA-DR+/CD38+
5.5
(2.0 to 13.8)
1.5
(-2.5 to 7.0)
-0.1
(-3.6 to 2.7)
-2.9
(-4.7 to -0.4)
4.Secondary Outcome
Title Change in Percent CD8 HLA-DR+/CD38+ From Baseline to Week 24 in Arm A and Arm C
Hide Description 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+.
Time Frame At Pre-entry, entry, Weeks 22 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title A: Chloroquine Then Placebo for Off-ART Participants C: Chloroquine Then Placebo for On-ART Participants
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 12 13
Median (Inter-Quartile Range)
Unit of Measure: percent of CD8 expressing HLA-DR+/CD38+
10.8
(0 to 14.8)
-2.4
(-4.5 to 0)
5.Secondary Outcome
Title Change in Total CD4 T Cell Count From Baseline to Week 12
Hide Description Baseline CD4 count (mean of pre-entry and entry CD4 count) is subtracted from the mean of week 10 and week 12 CD4 count
Time Frame At pre-entry, entry, weeks 10 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title A: Chloroquine Then Placebo for Off-ART Participants B: Placebo Then Chloroquine for Off-ART Participants C: Chloroquine Then Placebo for On-ART Participants D: Placebo Then Chloroquine for On-ART Participants
Hide Arm/Group Description:

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.

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.

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.

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 Number of Participants Analyzed 15 16 16 19
Median (Inter-Quartile Range)
Unit of Measure: cells/mm^3
-27
(-150 to 4)
-11
(-38 to 71)
-6
(-21 to 10)
7
(-17 to 23)
6.Secondary Outcome
Title Number of Participants With Events Grade 3 or Higher
Hide Description 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.
Time Frame From start of study treatment to study completion at week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on all enrolled participants, off-ART and on-ART, who received study treatment.
Arm/Group Title A: Chloroquine Then Placebo for Off-ART Participants B: Placebo Then Chloroquine for Off-ART Participants C: Chloroquine Then Placebo for On-ART Participants D: Placebo Then Chloroquine for On-ART Participants
Hide Arm/Group Description:

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.

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.

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.

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 Number of Participants Analyzed 16 17 18 19
Measure Type: Number
Unit of Measure: participants
0 1 1 0
7.Secondary Outcome
Title HIV-1 RNA Copies/mL at Study Entry for Off-ART Participants
Hide Description Results reported are for HIV-1 RNA (copies/mL) at study entry for off-ART participants.
Time Frame At Entry
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on all off-ART participants with HIV-1 RNA data at entry.
Arm/Group Title A: Chloroquine Then Placebo for Off-ART Participants B: Placebo Then Chloroquine for Off-ART Participants
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 16 17
Median (Inter-Quartile Range)
Unit of Measure: log10 copies/mL
4.48
(4.02 to 4.74)
4.42
(4.03 to 4.83)
8.Secondary Outcome
Title HIV-1 RNA Copies/mL at Weeks 12 and 24 for Off-ART Participants
Hide Description Results reported are for HIV-1 RNA (copies/mL) at week 12 and week 24 for off-ART participants.
Time Frame At weeks 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on all off-ART participants with HIV-1 RNA data at week 12 and week 24.
Arm/Group Title A: Chloroquine Then Placebo for Off-ART Participants B: Placebo Then Chloroquine for Off-ART Participants
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 14 16
Median (Inter-Quartile Range)
Unit of Measure: log10 copies/mL
Week 12
4.68
(4.46 to 4.79)
4.28
(4.08 to 4.60)
Week 24
4.69
(4.31 to 4.90)
4.61
(4.45 to 4.87)
9.Secondary Outcome
Title HIV-1 RNA Copies/mL at Study Entry for On-ART Participants
Hide Description Results reported are for HIV-1 RNA at study entry for on-ART participants.
Time Frame At Entry
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on all on-ART participants with HIV-1 RNA data at entry.
Arm/Group Title C: Chloroquine Then Placebo for On-ART Participants D: Placebo Then Chloroquine for On-ART Participants
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 18 19
Measure Type: Number
Unit of Measure: participants
at or below lower limit of quantitation 16 17
above lower limit of quantitation 2 2
10.Secondary Outcome
Title HIV-1 RNA Copies/mL at Week 12 for On-ART Participants
Hide Description Results reported are for HIV-1 RNA at week 12 for on-ART participants.
Time Frame At week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on all on-ART participants with HIV-1 RNA data at week 12.
Arm/Group Title C: Chloroquine Then Placebo for On-ART Participants D: Placebo Then Chloroquine for On-ART Participants
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 17 19
Measure Type: Number
Unit of Measure: participants
at or below lower limit of quantitation 16 18
above lower limit of quantitation 1 1
11.Secondary Outcome
Title HIV-1 RNA Copies/mL at Week 24 for On-ART Participants
Hide Description Results reported are for HIV-1 RNA at week 24 for on-ART participants.
Time Frame At week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on all on-ART participants with HIV-1 RNA data at week 24.
Arm/Group Title C: Chloroquine Then Placebo for On-ART Participants D: Placebo Then Chloroquine for On-ART Participants
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 16 19
Measure Type: Number
Unit of Measure: participants
at or below lower limit of quantitation 14 18
above lower limit of quantitation 2 1
12.Secondary Outcome
Title Percent CD8 CD38+ at Baseline
Hide Description Baseline CD8 CD38+ is computed as the mean of pre-entry and entry CD8 CD38+.
Time Frame At pre-entry and entry
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on all participants with assay data at pre-entry or entry.
Arm/Group Title A: Chloroquine Then Placebo for Off-ART Participants B: Placebo Then Chloroquine for Off-ART Participants C: Chloroquine Then Placebo for On-ART Participants D: Placebo Then Chloroquine for On-ART Participants
Hide Arm/Group Description:

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.

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.

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.

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 Number of Participants Analyzed 15 16 17 19
Median (Inter-Quartile Range)
Unit of Measure: percent of CD8 expressing CD38+
71.0
(66.0 to 80.5)
77.0
(71.5 to 88.3)
50.8
(40.1 to 65.6)
49.9
(37.8 to 63.5)
13.Secondary Outcome
Title Percent CD8 CD38+ at Week 12
Hide Description Results reported are the week 12 percentage of CD8 expressing CD38+.
Time Frame At Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on all participants with assay data at week 12.
Arm/Group Title A: Chloroquine Then Placebo for Off-ART Participants B: Placebo Then Chloroquine for Off-ART Participants C: Chloroquine Then Placebo for On-ART Participants D: Placebo Then Chloroquine for On-ART Participants
Hide Arm/Group Description:

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.

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.

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.

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 Number of Participants Analyzed 14 16 16 19
Median (Inter-Quartile Range)
Unit of Measure: percent of CD8 expressing CD38+
71.5
(67.0 to 83.0)
79.5
(69.0 to 88.5)
50.9
(37.2 to 63.6)
51.9
(38.7 to 63.0)
14.Secondary Outcome
Title Percent CD8 CD38+ at Week 24
Hide Description Results reported are the week 24 percentage of CD8 expressing CD38+.
Time Frame At Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on all participants with assay data at week 24.
Arm/Group Title A: Chloroquine Then Placebo for Off-ART Participants B: Placebo Then Chloroquine for Off-ART Participants C: Chloroquine Then Placebo for On-ART Participants D: Placebo Then Chloroquine for On-ART Participants
Hide Arm/Group Description:

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.

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.

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.

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 Number of Participants Analyzed 13 14 16 19
Median (Inter-Quartile Range)
Unit of Measure: percent of CD8 expressing CD38+
78.0
(74.0 to 86.0)
79.5
(69.0 to 89.0)
50.6
(40.6 to 54.4)
48.7
(38.2 to 64.9)
15.Secondary Outcome
Title Percent CD4 HLA-DR+/CD38+ at Baseline
Hide Description Baseline CD4 HLA-DR+/CD38+ is computed as the mean of pre-entry and entry CD4 HLA-DR+/CD38+.
Time Frame At pre-entry and entry
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on all participants with assay data at pre-entry or entry.
Arm/Group Title A: Chloroquine Then Placebo for Off-ART Participants B: Placebo Then Chloroquine for Off-ART Participants C: Chloroquine Then Placebo for On-ART Participants D: Placebo Then Chloroquine for On-ART Participants
Hide Arm/Group Description:

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.

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.

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.

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 Number of Participants Analyzed 15 16 17 19
Median (Inter-Quartile Range)
Unit of Measure: percent of CD4 expressing HLA-DR+/CD38+
8.5
(5.5 to 12.0)
9.8
(8.8 to 14.3)
8.7
(6.9 to 10.0)
9.9
(6.8 to 12.3)
16.Secondary Outcome
Title Percent CD4 HLA-DR+/CD38+ at Week 12
Hide Description Results reported are the week 12 percentage of CD4 expressing HLA-DR+/CD38+.
Time Frame At Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on all participants with assay data at week 12.
Arm/Group Title A: Chloroquine Then Placebo for Off-ART Participants B: Placebo Then Chloroquine for Off-ART Participants C: Chloroquine Then Placebo for On-ART Participants D: Placebo Then Chloroquine for On-ART Participants
Hide Arm/Group Description:

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.

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.

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.

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 Number of Participants Analyzed 14 16 16 19
Median (Inter-Quartile Range)
Unit of Measure: percent of CD4 expressing HLA-DR+/CD38+
6.5
(4.0 to 13.0)
10.5
(8.0 to 14.0)
7.7
(4.2 to 9.2)
9.0
(7.0 to 14.0)
17.Secondary Outcome
Title Percent CD4 HLA-DR+/CD38+ at Week 24
Hide Description Results reported are the week 24 percentage of CD4 expressing HLA-DR+/CD38+.
Time Frame At Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on all participants with assay data at week 24.
Arm/Group Title A: Chloroquine Then Placebo for Off-ART Participants B: Placebo Then Chloroquine for Off-ART Participants C: Chloroquine Then Placebo for On-ART Participants D: Placebo Then Chloroquine for On-ART Participants
Hide Arm/Group Description:

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.

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.

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.

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 Number of Participants Analyzed 13 14 16 19
Median (Inter-Quartile Range)
Unit of Measure: percent of CD4 expressing HLA-DR+/CD38+
11.0
(6.0 to 14.0)
12.5
(8.0 to 18.0)
7.3
(6.0 to 8.5)
9.2
(7.8 to 13.4)
18.Secondary Outcome
Title IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Baseline
Hide Description 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.
Time Frame At pre-entry and entry
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on all participants with assay data at pre-entry or entry.
Arm/Group Title A: Chloroquine Then Placebo for Off-ART Participants B: Placebo Then Chloroquine for Off-ART Participants C: Chloroquine Then Placebo for On-ART Participants D: Placebo Then Chloroquine for On-ART Participants
Hide Arm/Group Description:

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.

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.

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.

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 Number of Participants Analyzed 15 16 17 19
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
IL-6
1.65
(0.77 to 2.66)
1.62
(0.97 to 1.97)
1.01
(0.72 to 1.56)
1.51
(1.01 to 1.92)
sTNF-rI
1228.66
(992.52 to 1359.06)
1377.81
(1086.72 to 1558.35)
1316.63
(1127.96 to 1487.45)
1250.85
(995.60 to 1591.80)
D-dimer
286390
(162780 to 541950)
328460
(188690 to 422650)
107890
(88440 to 151810)
103530
(71420 to 193330)
19.Secondary Outcome
Title IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Week 12
Hide Description Results reported are the week 12 IL-6, sTNF-rI and D-dimer.
Time Frame At week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on all participants with assay data at week 12.
Arm/Group Title A: Chloroquine Then Placebo for Off-ART Participants B: Placebo Then Chloroquine for Off-ART Participants C: Chloroquine Then Placebo for On-ART Participants D: Placebo Then Chloroquine for On-ART Participants
Hide Arm/Group Description:

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.

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.

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.

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 Number of Participants Analyzed 13 16 15 18
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
IL-6
1.68
(0.96 to 2.35)
1.28
(0.96 to 2.79)
1.15
(0.79 to 2.07)
1.30
(1.06 to 2.31)
sTNF-rI
1209.50
(1027.01 to 1385.70)
1347.06
(1242.37 to 1538.05)
1441.35
(1149.16 to 1711.86)
1304.77
(1092.70 to 1473.54)
D-dimer
251320
(161660 to 621030)
319770
(189170 to 582040)
126540
(102190 to 179220)
117890
(73540 to 207890)
20.Secondary Outcome
Title IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Week 24
Hide Description Results reported are the week 24 IL-6, sTNF-rI and D-dimer.
Time Frame At week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on all participants with assay data at week 24.
Arm/Group Title A: Chloroquine Then Placebo for Off-ART Participants B: Placebo Then Chloroquine for Off-ART Participants C: Chloroquine Then Placebo for On-ART Participants D: Placebo Then Chloroquine for On-ART Participants
Hide Arm/Group Description:

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.

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.

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.

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 Number of Participants Analyzed 14 16 16 19
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
IL-6
1.34
(1.10 to 2.34)
1.18
(0.84 to 2.74)
1.02
(0.80 to 1.45)
1.27
(1.01 to 2.33)
sTNF-rI
1327.21
(1056.79 to 1602.16)
1420.30
(1229.57 to 1600.32)
1230.21
(1063.46 to 1358.30)
1176.20
(1060.28 to 1629.53)
D-dimer
264240
(210110 to 380880)
294780
(215400 to 615550)
100860
(78400 to 128350)
124920
(83130 to 182450)
21.Secondary Outcome
Title Soluble CD14 (sCD14) at Baseline
Hide Description Baseline sCD14 was computed as the mean of pre-entry and entry sCD14.
Time Frame At pre-entry and entry
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on all participants with assay data at pre-entry or entry.
Arm/Group Title A: Chloroquine Then Placebo for Off-ART Participants B: Placebo Then Chloroquine for Off-ART Participants C: Chloroquine Then Placebo for On-ART Participants D: Placebo Then Chloroquine for On-ART Participants
Hide Arm/Group Description:

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.

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.

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.

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 Number of Participants Analyzed 15 16 17 19
Median (Inter-Quartile Range)
Unit of Measure: million pg/mL
1.43
(1.23 to 1.79)
1.97
(1.77 to 2.27)
1.80
(1.65 to 2.18)
1.58
(1.39 to 1.87)
22.Secondary Outcome
Title Soluble CD14 (sCD14) at Week 12
Hide Description Results reported are the week 12 sCD14.
Time Frame At week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on all participants with assay data at week 12.
Arm/Group Title A: Chloroquine Then Placebo for Off-ART Participants B: Placebo Then Chloroquine for Off-ART Participants C: Chloroquine Then Placebo for On-ART Participants D: Placebo Then Chloroquine for On-ART Participants
Hide Arm/Group Description:

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.

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.

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.

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 Number of Participants Analyzed 13 16 15 18
Median (Inter-Quartile Range)
Unit of Measure: million pg/mL
1.53
(1.39 to 2.05)
1.88
(1.64 to 2.30)
2.04
(1.60 to 2.21)
1.63
(1.35 to 1.82)
23.Secondary Outcome
Title Soluble CD14 (sCD14) at Week 24
Hide Description Results reported are the week 24 sCD14.
Time Frame At week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on all participants with assay data at week 24.
Arm/Group Title A: Chloroquine Then Placebo for Off-ART Participants B: Placebo Then Chloroquine for Off-ART Participants C: Chloroquine Then Placebo for On-ART Participants D: Placebo Then Chloroquine for On-ART Participants
Hide Arm/Group Description:

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.

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.

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.

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 Number of Participants Analyzed 14 16 16 19
Median (Inter-Quartile Range)
Unit of Measure: million pg/mL
1.53
(1.37 to 1.97)
2.19
(1.79 to 2.35)
1.77
(1.49 to 2.39)
1.72
(1.54 to 2.15)
24.Secondary Outcome
Title Fasting Lipopolysaccharides (LPS) at Entry
Hide Description Results reported are for entry fasting LPS.
Time Frame At entry
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on all participants with assay data at entry.
Arm/Group Title A: Chloroquine Then Placebo for Off-ART Participants B: Placebo Then Chloroquine for Off-ART Participants C: Chloroquine Then Placebo for On-ART Participants D: Placebo Then Chloroquine for On-ART Participants
Hide Arm/Group Description:

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.

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.

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.

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 Number of Participants Analyzed 15 16 17 19
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
13.68
(3.79 to 31.38)
1.64
(0.70 to 28.98)
8.00
(6.00 to 10.00)
7.00
(2.00 to 8.00)
25.Secondary Outcome
Title Fasting Lipopolysaccharides (LPS) at Week 12
Hide Description Results reported are the week 12 fasting LPS.
Time Frame At week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on all participants with assay data at week 12.
Arm/Group Title A: Chloroquine Then Placebo for Off-ART Participants B: Placebo Then Chloroquine for Off-ART Participants C: Chloroquine Then Placebo for On-ART Participants D: Placebo Then Chloroquine for On-ART Participants
Hide Arm/Group Description:

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.

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.

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.

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 Number of Participants Analyzed 14 16 15 18
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
14.37
(4.26 to 36.63)
13.06
(0.70 to 36.58)
7.00
(6.00 to 9.00)
7.00
(4.00 to 9.00)
26.Secondary Outcome
Title Fasting Lipopolysaccharides (LPS) at Week 24
Hide Description Results reported are the week 24 fasting LPS.
Time Frame At week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on all participants with assay data at week 24.
Arm/Group Title A: Chloroquine Then Placebo for Off-ART Participants B: Placebo Then Chloroquine for Off-ART Participants C: Chloroquine Then Placebo for On-ART Participants D: Placebo Then Chloroquine for On-ART Participants
Hide Arm/Group Description:

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.

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.

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.

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 Number of Participants Analyzed 14 16 16 19
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
20.54
(7.56 to 37.80)
2.83
(0.70 to 30.57)
7.00
(6.00 to 9.00)
8.00
(6.00 to 10.00)
27.Secondary Outcome
Title Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Baseline
Hide Description 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.
Time Frame At pre-entry and entry
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on all participants with assay data at pre-entry or entry.
Arm/Group Title A: Chloroquine Then Placebo for Off-ART Participants B: Placebo Then Chloroquine for Off-ART Participants C: Chloroquine Then Placebo for On-ART Participants D: Placebo Then Chloroquine for On-ART Participants
Hide Arm/Group Description:

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.

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.

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.

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 Number of Participants Analyzed 16 17 18 19
Median (Inter-Quartile Range)
Unit of Measure: percentage of cells
%pDC expressing CD80+
0.03
(0.00 to 0.10)
0.03
(0.00 to 0.07)
0.13
(0.07 to 0.18)
0.07
(0.05 to 0.20)
%pDC expressing CD83+
45.48
(28.93 to 59.40)
36.15
(27.18 to 52.28)
19.91
(13.98 to 26.58)
23.65
(7.49 to 27.99)
%pDC expressing CD86+
9.12
(7.01 to 10.79)
9.35
(6.33 to 11.65)
10.96
(5.90 to 14.04)
12.66
(8.28 to 17.91)
%pDC expressing PDL-1+
2.52
(2.00 to 6.16)
6.13
(3.01 to 12.99)
4.48
(2.53 to 8.36)
6.49
(2.48 to 12.03)
%mDC expressing CD80+
1.04
(0.45 to 1.49)
0.83
(0.47 to 1.01)
1.31
(0.73 to 1.62)
1.17
(0.76 to 2.30)
%mDC expressing CD83+
38.60
(9.51 to 55.88)
39.94
(21.98 to 59.07)
48.17
(35.51 to 65.88)
26.08
(12.46 to 53.69)
%mDC expressing CD86+
96.29
(94.13 to 98.55)
97.52
(95.69 to 98.50)
96.11
(94.31 to 98.30)
95.38
(90.57 to 96.69)
%mDC expressing PDL-1+
9.82
(6.32 to 13.54)
16.37
(7.76 to 30.19)
4.58
(2.71 to 7.93)
8.28
(3.08 to 11.50)
28.Secondary Outcome
Title Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 12
Hide Description Results reported are the week 12 percent activation levels of pDC and mDC.
Time Frame At week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on all participants with assay data at week 12.
Arm/Group Title A: Chloroquine Then Placebo for Off-ART Participants B: Placebo Then Chloroquine for Off-ART Participants C: Chloroquine Then Placebo for On-ART Participants D: Placebo Then Chloroquine for On-ART Participants
Hide Arm/Group Description:

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.

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.

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.

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 Number of Participants Analyzed 13 16 17 19
Median (Inter-Quartile Range)
Unit of Measure: percentage of cells
%pDC expressing CD80+
0.00
(0.00 to 0.03)
0.05
(0.00 to 0.15)
0.10
(0.00 to 0.20)
0.14
(0.00 to 0.40)
%pDC expressing CD83+
51.90
(22.60 to 55.60)
40.49
(30.35 to 47.90)
14.70
(8.28 to 24.77)
18.20
(8.08 to 32.30)
%pDC expressing CD86+
7.66
(6.50 to 8.52)
8.48
(5.26 to 12.22)
13.93
(6.55 to 17.84)
13.64
(8.63 to 18.09)
%pDC expressing PDL-1+
3.74
(2.66 to 5.98)
8.43
(3.27 to 16.53)
7.24
(2.24 to 10.67)
5.16
(2.80 to 12.72)
%mDC expressing CD80+
0.84
(0.59 to 1.12)
1.03
(0.68 to 1.71)
1.47
(0.95 to 1.87)
1.01
(0.90 to 2.28)
%mDC expressing CD83+
43.51
(20.34 to 51.74)
36.47
(27.54 to 46.41)
47.83
(32.32 to 65.29)
26.75
(13.60 to 51.40)
%mDC expressing CD86+
97.90
(96.99 to 98.51)
97.18
(96.30 to 98.65)
95.40
(91.26 to 97.20)
95.15
(87.18 to 96.38)
%mDC expressing PDL-1+
15.03
(9.12 to 17.48)
16.32
(9.49 to 36.81)
7.10
(3.18 to 10.56)
6.09
(2.69 to 15.81)
29.Secondary Outcome
Title Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 24
Hide Description Results reported are the week 24 percent activation levels of pDC and mDC.
Time Frame At week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on all participants with assay data at week 24.
Arm/Group Title A: Chloroquine Then Placebo for Off-ART Participants B: Placebo Then Chloroquine for Off-ART Participants C: Chloroquine Then Placebo for On-ART Participants D: Placebo Then Chloroquine for On-ART Participants
Hide Arm/Group Description:

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.

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.

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.

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 Number of Participants Analyzed 14 16 16 18
Median (Inter-Quartile Range)
Unit of Measure: percentage of cells
%pDC expressing CD80+
0.05
(0.00 to 0.08)
0.00
(0.00 to 0.05)
0.08
(0.03 to 0.18)
0.16
(0.05 to 0.23)
%pDC expressing CD83+
44.50
(26.60 to 60.30)
38.96
(23.17 to 45.51)
14.80
(7.90 to 25.62)
17.65
(7.78 to 21.44)
%pDC expressing CD86+
10.13
(7.12 to 10.73)
7.89
(4.86 to 12.61)
11.79
(6.81 to 20.98)
12.88
(8.99 to 19.21)
%pDC expressing PDL-1+
4.34
(1.70 to 8.08)
7.45
(2.83 to 15.09)
5.63
(2.53 to 10.83)
6.52
(1.05 to 12.69)
%mDC expressing CD80+
0.94
(0.36 to 1.28)
1.12
(0.67 to 1.34)
0.76
(0.65 to 1.38)
1.39
(0.89 to 2.00)
%mDC expressing CD83+
41.21
(25.74 to 49.61)
33.19
(24.04 to 47.68)
36.65
(22.35 to 52.38)
24.14
(12.93 to 36.67)
%mDC expressing CD86+
97.70
(95.80 to 99.04)
97.05
(95.40 to 98.31)
96.69
(92.46 to 97.89)
92.41
(89.01 to 97.20)
%mDC expressing PDL-1+
9.53
(6.31 to 18.85)
14.84
(11.11 to 40.45)
4.13
(2.14 to 11.82)
7.49
(3.15 to 13.64)
Time Frame AEs reported from start of study treatment until study completion at 28 weeks.
Adverse Event Reporting Description AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
 
Arm/Group Title A: Chloroquine Then Placebo for Off-ART Participants B: Placebo Then Chloroquine for Off-ART Participants C: Chloroquine Then Placebo for On-ART Participants D: Placebo Then Chloroquine for On-ART Participants
Hide Arm/Group Description

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.

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.

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.

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.

All-Cause Mortality
A: Chloroquine Then Placebo for Off-ART Participants B: Placebo Then Chloroquine for Off-ART Participants C: Chloroquine Then Placebo for On-ART Participants D: Placebo Then Chloroquine for On-ART Participants
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
A: Chloroquine Then Placebo for Off-ART Participants B: Placebo Then Chloroquine for Off-ART Participants C: Chloroquine Then Placebo for On-ART Participants D: Placebo Then Chloroquine for On-ART Participants
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/16 (6.25%)   1/17 (5.88%)   3/18 (16.67%)   1/19 (5.26%) 
Gastrointestinal disorders         
Abdominal pain  1  1/16 (6.25%)  0/17 (0.00%)  0/18 (0.00%)  0/19 (0.00%) 
Infections and infestations         
Pneumonia  1  0/16 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/19 (0.00%) 
Nervous system disorders         
Cerebrovascular accident  1  0/16 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/19 (0.00%) 
Psychiatric disorders         
Abnormal behaviour  1  0/16 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/19 (0.00%) 
Suicidal ideation  1  0/16 (0.00%)  1/17 (5.88%)  0/18 (0.00%)  0/19 (0.00%) 
Suicide attempt  1  0/16 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  1/19 (5.26%) 
Respiratory, thoracic and mediastinal disorders         
Pulmonary embolism  1  0/16 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  1/19 (5.26%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
A: Chloroquine Then Placebo for Off-ART Participants B: Placebo Then Chloroquine for Off-ART Participants C: Chloroquine Then Placebo for On-ART Participants D: Placebo Then Chloroquine for On-ART Participants
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/16 (62.50%)   12/17 (70.59%)   10/18 (55.56%)   7/19 (36.84%) 
Blood and lymphatic system disorders         
Lymphadenopathy  1  0/16 (0.00%)  1/17 (5.88%)  0/18 (0.00%)  0/19 (0.00%) 
Ear and labyrinth disorders         
Ear pain  1  1/16 (6.25%)  0/17 (0.00%)  1/18 (5.56%)  0/19 (0.00%) 
Tinnitus  1  1/16 (6.25%)  0/17 (0.00%)  0/18 (0.00%)  0/19 (0.00%) 
Endocrine disorders         
Hypothyroidism  1  0/16 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  1/19 (5.26%) 
Eye disorders         
Blepharitis  1  0/16 (0.00%)  1/17 (5.88%)  0/18 (0.00%)  0/19 (0.00%) 
Dry eye  1  0/16 (0.00%)  1/17 (5.88%)  0/18 (0.00%)  0/19 (0.00%) 
Eye pain  1  0/16 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/19 (0.00%) 
Oculogyric crisis  1  0/16 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/19 (0.00%) 
Retinal depigmentation  1  0/16 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/19 (0.00%) 
Retinal pigmentation  1  0/16 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/19 (0.00%) 
Vision blurred  1  0/16 (0.00%)  1/17 (5.88%)  1/18 (5.56%)  0/19 (0.00%) 
Visual impairment  1  2/16 (12.50%)  0/17 (0.00%)  0/18 (0.00%)  0/19 (0.00%) 
Gastrointestinal disorders         
Anogenital dysplasia  1  0/16 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/19 (0.00%) 
Gastrooesophageal reflux disease  1  0/16 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  1/19 (5.26%) 
General disorders         
Chest discomfort  1  0/16 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/19 (0.00%) 
Chest pain  1  0/16 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  1/19 (5.26%) 
Infections and infestations         
Acute hepatitis C  1  0/16 (0.00%)  1/17 (5.88%)  0/18 (0.00%)  0/19 (0.00%) 
Bacterial infection  1  0/16 (0.00%)  1/17 (5.88%)  0/18 (0.00%)  0/19 (0.00%) 
Conjunctivitis  1  0/16 (0.00%)  1/17 (5.88%)  0/18 (0.00%)  0/19 (0.00%) 
Genitourinary chlamydia infection  1  0/16 (0.00%)  1/17 (5.88%)  0/18 (0.00%)  0/19 (0.00%) 
Hepatitis C  1  0/16 (0.00%)  1/17 (5.88%)  0/18 (0.00%)  0/19 (0.00%) 
Herpes simplex  1  0/16 (0.00%)  1/17 (5.88%)  0/18 (0.00%)  0/19 (0.00%) 
Latent syphilis  1  0/16 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  1/19 (5.26%) 
Oesophageal candidiasis  1  0/16 (0.00%)  1/17 (5.88%)  0/18 (0.00%)  0/19 (0.00%) 
Onychomycosis  1  0/16 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  1/19 (5.26%) 
Oropharyngeal candidiasis  1  0/16 (0.00%)  1/17 (5.88%)  0/18 (0.00%)  0/19 (0.00%) 
Otitis media  1  0/16 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  1/19 (5.26%) 
Pharyngitis  1  0/16 (0.00%)  1/17 (5.88%)  0/18 (0.00%)  0/19 (0.00%) 
Pneumonia bacterial  1  0/16 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/19 (0.00%) 
Secondary syphilis  1  1/16 (6.25%)  0/17 (0.00%)  0/18 (0.00%)  0/19 (0.00%) 
Tinea pedis  1  0/16 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  1/19 (5.26%) 
Upper respiratory tract infection  1  1/16 (6.25%)  0/17 (0.00%)  0/18 (0.00%)  1/19 (5.26%) 
Vulvovaginitis trichomonal  1  1/16 (6.25%)  0/17 (0.00%)  0/18 (0.00%)  0/19 (0.00%) 
Injury, poisoning and procedural complications         
Ankle fracture  1  1/16 (6.25%)  0/17 (0.00%)  0/18 (0.00%)  0/19 (0.00%) 
Overdose  1  1/16 (6.25%)  0/17 (0.00%)  0/18 (0.00%)  0/19 (0.00%) 
Investigations         
Alanine aminotransferase increased  1  2/16 (12.50%)  1/17 (5.88%)  1/18 (5.56%)  0/19 (0.00%) 
Aspartate aminotransferase increased  1  2/16 (12.50%)  3/17 (17.65%)  1/18 (5.56%)  0/19 (0.00%) 
Blood albumin abnormal  1  1/16 (6.25%)  2/17 (11.76%)  0/18 (0.00%)  0/19 (0.00%) 
Blood alkaline phosphatase abnormal  1  0/16 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  1/19 (5.26%) 
Blood alkaline phosphatase increased  1  0/16 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  1/19 (5.26%) 
Blood bilirubin increased  1  1/16 (6.25%)  1/17 (5.88%)  1/18 (5.56%)  1/19 (5.26%) 
Blood cholesterol  1  0/16 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/19 (0.00%) 
Blood creatinine increased  1  0/16 (0.00%)  1/17 (5.88%)  0/18 (0.00%)  0/19 (0.00%) 
Blood glucose abnormal  1  2/16 (12.50%)  2/17 (11.76%)  0/18 (0.00%)  0/19 (0.00%) 
Blood glucose increased  1  0/16 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  1/19 (5.26%) 
Blood phosphorus decreased  1  0/16 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/19 (0.00%) 
Blood potassium decreased  1  1/16 (6.25%)  0/17 (0.00%)  0/18 (0.00%)  0/19 (0.00%) 
Blood potassium increased  1  0/16 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/19 (0.00%) 
Blood sodium decreased  1  0/16 (0.00%)  1/17 (5.88%)  0/18 (0.00%)  0/19 (0.00%) 
Neutrophil count decreased  1  1/16 (6.25%)  1/17 (5.88%)  1/18 (5.56%)  0/19 (0.00%) 
Platelet count decreased  1  0/16 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/19 (0.00%) 
Metabolism and nutrition disorders         
Decreased appetite  1  0/16 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/19 (0.00%) 
Musculoskeletal and connective tissue disorders         
Back pain  1  0/16 (0.00%)  1/17 (5.88%)  1/18 (5.56%)  0/19 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Anorectal human papilloma virus infection  1  0/16 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/19 (0.00%) 
Basal cell carcinoma  1  1/16 (6.25%)  0/17 (0.00%)  0/18 (0.00%)  0/19 (0.00%) 
Fibrous histiocytoma  1  0/16 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/19 (0.00%) 
Penile wart  1  0/16 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/19 (0.00%) 
Seborrhoeic keratosis  1  0/16 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/19 (0.00%) 
Skin papilloma  1  0/16 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/19 (0.00%) 
Nervous system disorders         
Balance disorder  1  0/16 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/19 (0.00%) 
Dizziness  1  0/16 (0.00%)  1/17 (5.88%)  1/18 (5.56%)  0/19 (0.00%) 
Headache  1  0/16 (0.00%)  0/17 (0.00%)  2/18 (11.11%)  0/19 (0.00%) 
Psychiatric disorders         
Acute psychosis  1  0/16 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/19 (0.00%) 
Agitation  1  0/16 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/19 (0.00%) 
Anxiety  1  0/16 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/19 (0.00%) 
Confusional state  1  0/16 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/19 (0.00%) 
Dependence  1  1/16 (6.25%)  0/17 (0.00%)  0/18 (0.00%)  0/19 (0.00%) 
Depressed mood  1  0/16 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/19 (0.00%) 
Hallucination, auditory  1  0/16 (0.00%)  1/17 (5.88%)  0/18 (0.00%)  0/19 (0.00%) 
Hallucination, visual  1  0/16 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/19 (0.00%) 
Insomnia  1  0/16 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/19 (0.00%) 
Paranoia  1  0/16 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/19 (0.00%) 
Suicidal ideation  1  0/16 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  1/19 (5.26%) 
Reproductive system and breast disorders         
Scrotal varicose veins  1  0/16 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/19 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Dyspnoea  1  0/16 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  1/19 (5.26%) 
Oropharyngeal pain  1  0/16 (0.00%)  1/17 (5.88%)  0/18 (0.00%)  0/19 (0.00%) 
Productive cough  1  0/16 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/19 (0.00%) 
Respiratory tract congestion  1  0/16 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/19 (0.00%) 
Wheezing  1  0/16 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/19 (0.00%) 
Skin and subcutaneous tissue disorders         
Dermatitis atopic  1  0/16 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/19 (0.00%) 
Dermatosis  1  0/16 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  1/19 (5.26%) 
Social circumstances         
Poor personal hygiene  1  0/16 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/19 (0.00%) 
Vascular disorders         
Hypertension  1  0/16 (0.00%)  1/17 (5.88%)  0/18 (0.00%)  1/19 (5.26%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: ACTG Clinicaltrials.gov Coordinator
Organization: ACTG Network Coordinating Center, Social and Scientific Systems
Phone: (301) 628-3313
EMail: ACTGCT.Gov@s-3.com
Layout table for additonal information
Responsible Party: AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00819390    
Other Study ID Numbers: ACTG A5258
1U01AI068636 ( U.S. NIH Grant/Contract )
First Submitted: January 8, 2009
First Posted: January 9, 2009
Results First Submitted: August 26, 2014
Results First Posted: September 5, 2014
Last Update Posted: October 13, 2014