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| ID | Type | Description | Link |
|---|---|---|---|
| 1U01AI068636 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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HIV is characterized by frequent immune system activation. Early in the course of infection the body establishes an immune activation "set point" related to the amount of HIV in the blood stream. This set point affects the rate of CD4 cell loss. Without CD4 cells, or with very low levels of CD4 cells, the body cannot fight off illness. This is known as immunodeficiency. If left untreated HIV can lead to extreme immunodeficiency and AIDS.
Evidence suggests that by decreasing the rate of immune system activation, immune deficiency progression could be prevented. The purpose of this study is to learn how well chloroquine can reduce the level of immune activation and to test the safety and tolerance of chloroquine in people infected with HIV.
HIV is characterized by persistent immune system activation, and early in the course of infection the body establishes an immune activation "set point" related to the amount of HIV in the blood stream. This set point affects the rate of CD4 cell loss. Without CD4 cells, or with very low levels of CD4 cells, the body cannot fight off illness. This is known as immunodeficiency. If left untreated HIV can lead to extreme immunodeficiency and AIDS.
Immune system activation includes activating the CD8 cells. These cells attack body cells infected with viruses. Because of this, CD4 cells infected with HIV are frequently destroyed by CD8 cells. The purpose of this study is to learn how well chloroquine reduces the level of activation of CD8 cells in people infected with HIV. Increased activation of CD8 cells is thought to lead to a more severe path of disease in HIV infection.
The constant immune activation observed in HIV- infected patients has also been linked to higher levels of byproducts from certain naturally occurring bacteria found in the gut that are known to be immune stimulants. By decreasing the stimulation from these byproducts with chloroquine treatment, HIV disease may be slowed.
The purpose of this study was to learn how well chloroquine reduces the level of activation of CD8 cells and lowers the levels of bacteria byproducts in people infected with HIV, either off antiretroviral therapy (ART) (protocol version 1.0 dated December 17, 2008) or on-ART (protocol version 2.0 dated October 1, 2010). The off-ART (Arms A and B) and on-ART (Arms C and D) participants were enrolled during different time periods, and the study was designed to analyze the two study populations separately. This study also looked at how well chloroquine was tolerated and its safety in HIV- infected participants.
Off-ART participants in the study were randomized with equal probability to one of two treatment arms:
Arm A: Participants received 12 weeks of chloroquine treatment followed by 12 weeks of placebo
Arm B: Participants received 12 weeks of placebo followed by 12 weeks of chloroquine
On-ART participants in the study were randomized with equal probability to one of two treatment arms:
Arm C: Participants received 12 weeks of chloroquine treatment followed by 12 weeks of placebo
Arm D: Participants received 12 weeks of placebo followed by 12 weeks of chloroquine
Study treatment was given once a day for a full 24 weeks. There was an additional 4 weeks of follow-up for purposes of safety. After treatment has started, participants were asked to come to the clinic on Weeks 4, 10, 12, 16, 22, and 24. At each visit participants were given enough study treatment to last until the next visit. Each visit lasted between 30 and 60 minutes. At most visits, participants had a physical exam, answered questions about any medications they were taking and how they are feeling, and had blood drawn for safety to assess CD4/CD8 cell counts and viral load. Some additional blood were also stored for immunology testing. At some visits, participants were asked questions about their medication and medical history, had pupils dilated, had a hearing test, and had an electrocardiogram (EKG). Some visits required participants to arrive fasting. Pregnancy tests were also conducted if the participant is able to become pregnant or if pregnancy was suspected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: Chloroquine then Placebo for Off-ART Participants | Experimental | 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. |
|
| B: Placebo then Chloroquine for Off-ART Participants | Experimental | 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. |
|
| C: Chloroquine then Placebo for On-ART Participants | Experimental | 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. |
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| D: Placebo then Chloroquine for On-ART Participants | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chloroquine | Drug | Taken orally, once daily, at a dose of 250 mg for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Percent CD8 HLA-DR+/CD38+ From Baseline to Week 12 | 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+. | At pre-entry, entry, weeks 10 and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Percent CD8 HLA-DR+/CD38+ From Start to End of the 12-week Chloroquine Treatment Period | 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+. |
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Inclusion Criteria:
Additional Inclusion Criteria for Off-ART Participants:
Additional Inclusion Criteria for On-ART Participants:
Exclusion Criteria:
Additional Exclusion Criteria for On-ART Participants:
- Plans to change ART regimen with the 6 months after study entry (change in ART regimen is only permitted if due to toxicity)
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey M Jacobson, MD | Drexel University College of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Therapeutics CRS (5801) | Birmingham | Alabama | 35294 | United States | ||
| Ucsd, Avrc Crs (701) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12913796 | Background | Neely M, Kalyesubula I, Bagenda D, Myers C, Olness K. Effect of chloroquine on human immunodeficiency virus (HIV) vertical transmission. Afr Health Sci. 2003 Aug;3(2):61-7. | |
| 14592603 | Background | Savarino A, Boelaert JR, Cassone A, Majori G, Cauda R. Effects of chloroquine on viral infections: an old drug against today's diseases? Lancet Infect Dis. 2003 Nov;3(11):722-7. doi: 10.1016/s1473-3099(03)00806-5. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Taken orally, once daily for 12 weeks. |
|
| For Arms A and C: Pre-entry, entry, weeks 10 and 12. For Arms B and D: Weeks 10, 12, 22 and 24 |
| Change in Percent CD8 HLA-DR+/CD38+ From Week 12 to Week 24 | 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+ | At Weeks 10, 12, 22 and 24 |
| Change in Percent CD8 HLA-DR+/CD38+ From Baseline to Week 24 in Arm A and Arm C | 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+. | At Pre-entry, entry, Weeks 22 and 24 |
| Change in Total CD4 T Cell Count From Baseline to Week 12 | Baseline CD4 count (mean of pre-entry and entry CD4 count) is subtracted from the mean of week 10 and week 12 CD4 count | At pre-entry, entry, weeks 10 and 12 |
| Number of Participants With Events Grade 3 or Higher | 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. | From start of study treatment to study completion at week 28 |
| HIV-1 RNA Copies/mL at Study Entry for Off-ART Participants | Results reported are for HIV-1 RNA (copies/mL) at study entry for off-ART participants. | At Entry |
| HIV-1 RNA Copies/mL at Weeks 12 and 24 for Off-ART Participants | Results reported are for HIV-1 RNA (copies/mL) at week 12 and week 24 for off-ART participants. | At weeks 12 and 24 |
| HIV-1 RNA Copies/mL at Study Entry for On-ART Participants | Results reported are for HIV-1 RNA at study entry for on-ART participants. | At Entry |
| HIV-1 RNA Copies/mL at Week 12 for On-ART Participants | Results reported are for HIV-1 RNA at week 12 for on-ART participants. | At week 12 |
| HIV-1 RNA Copies/mL at Week 24 for On-ART Participants | Results reported are for HIV-1 RNA at week 24 for on-ART participants. | At week 24 |
| Percent CD8 CD38+ at Baseline | Baseline CD8 CD38+ is computed as the mean of pre-entry and entry CD8 CD38+. | At pre-entry and entry |
| Percent CD8 CD38+ at Week 12 | Results reported are the week 12 percentage of CD8 expressing CD38+. | At Week 12 |
| Percent CD8 CD38+ at Week 24 | Results reported are the week 24 percentage of CD8 expressing CD38+. | At Week 24 |
| Percent CD4 HLA-DR+/CD38+ at Baseline | Baseline CD4 HLA-DR+/CD38+ is computed as the mean of pre-entry and entry CD4 HLA-DR+/CD38+. | At pre-entry and entry |
| Percent CD4 HLA-DR+/CD38+ at Week 12 | Results reported are the week 12 percentage of CD4 expressing HLA-DR+/CD38+. | At Week 12 |
| Percent CD4 HLA-DR+/CD38+ at Week 24 | Results reported are the week 24 percentage of CD4 expressing HLA-DR+/CD38+. | At Week 24 |
| IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Baseline | 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. | At pre-entry and entry |
| IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Week 12 | Results reported are the week 12 IL-6, sTNF-rI and D-dimer. | At week 12 |
| IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Week 24 | Results reported are the week 24 IL-6, sTNF-rI and D-dimer. | At week 24 |
| Soluble CD14 (sCD14) at Baseline | Baseline sCD14 was computed as the mean of pre-entry and entry sCD14. | At pre-entry and entry |
| Soluble CD14 (sCD14) at Week 12 | Results reported are the week 12 sCD14. | At week 12 |
| Soluble CD14 (sCD14) at Week 24 | Results reported are the week 24 sCD14. | At week 24 |
| Fasting Lipopolysaccharides (LPS) at Entry | Results reported are for entry fasting LPS. | At entry |
| Fasting Lipopolysaccharides (LPS) at Week 12 | Results reported are the week 12 fasting LPS. | At week 12 |
| Fasting Lipopolysaccharides (LPS) at Week 24 | Results reported are the week 24 fasting LPS. | At week 24 |
| Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Baseline | 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. | At pre-entry and entry |
| Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 12 | Results reported are the week 12 percent activation levels of pDC and mDC. | At week 12 |
| Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 24 | Results reported are the week 24 percent activation levels of pDC and mDC. | At week 24 |
| San Diego |
| California |
| 92103 |
| United States |
| University of Colorado Hospital CRS (6101) | Aurora | Colorado | 80045 | United States |
| Georgetown University CRS (GU CRS) (1008) | Washington D.C. | District of Columbia | 20007 | United States |
| Johns Hopkins Adult AIDS CRS (201) | Baltimore | Maryland | 21205 | United States |
| Massachusetts General Hospital ACTG CRS (101) | Boston | Massachusetts | 02114 | United States |
| Washington University CRS (2101) | St Louis | Missouri | 63110 | United States |
| Cornell CRS (7804) | New York | New York | 10011 | United States |
| Unc Aids Crs (3201) | Chapel Hill | North Carolina | 27514 | United States |
| Univ. of Cincinnati CRS (2401) | Cincinnati | Ohio | 45267 | United States |
| Case CRS (2501) | Cleveland | Ohio | 44106 | United States |
| MetroHealth CRS (2503) | Cleveland | Ohio | 44109 | United States |
| Hosp. of the Univ. of Pennsylvania CRS (6201) | Philadelphia | Pennsylvania | 19104 | United States |
| Pittsburgh CRS (1001) | Pittsburgh | Pennsylvania | 15213 | United States |
| Vanderbilt Therapeutics CRS (3652) | Nashville | Tennessee | 37204 | United States |
| 16772000 | Background | Semrau K, Kuhn L, Kasonde P, Sinkala M, Kankasa C, Shutes E, Vwalika C, Ghosh M, Aldrovandi G, Thea DM. Impact of chloroquine on viral load in breast milk. Trop Med Int Health. 2006 Jun;11(6):800-3. doi: 10.1111/j.1365-3156.2006.01645.x. |
| 26935044 | Derived | Jacobson JM, Bosinger SE, Kang M, Belaunzaran-Zamudio P, Matining RM, Wilson CC, Flexner C, Clagett B, Plants J, Read S, Purdue L, Myers L, Boone L, Tebas P, Kumar P, Clifford D, Douek D, Silvestri G, Landay AL, Lederman MM. The Effect of Chloroquine on Immune Activation and Interferon Signatures Associated with HIV-1. AIDS Res Hum Retroviruses. 2016 Jul;32(7):636-47. doi: 10.1089/AID.2015.0336. Epub 2016 Apr 19. |
| FG001 |
| 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. |
| FG002 | 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. |
| FG003 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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|
Results are for all participants, off-ART and on-ART, who enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
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| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change in Percent CD8 HLA-DR+/CD38+ From Baseline to Week 12 | 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+. | 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). | Median | Inter-Quartile Range | percent of CD8 expressing HLA-DR+/CD38+ | At pre-entry, entry, weeks 10 and 12 |
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| Secondary | Change in Percent CD8 HLA-DR+/CD38+ From Start to End of the 12-week Chloroquine Treatment Period | 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+. | 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). | Median | Inter-Quartile Range | percent of CD8 expressing HLA-DR+/CD38+ | For Arms A and C: Pre-entry, entry, weeks 10 and 12. For Arms B and D: Weeks 10, 12, 22 and 24 |
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| Secondary | Change in Percent CD8 HLA-DR+/CD38+ From Week 12 to Week 24 | 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+ | 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). | Median | Inter-Quartile Range | percent of CD8 expressing HLA-DR+/CD38+ | At Weeks 10, 12, 22 and 24 |
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| Secondary | Change in Percent CD8 HLA-DR+/CD38+ From Baseline to Week 24 in Arm A and Arm C | 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+. | 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). | Median | Inter-Quartile Range | percent of CD8 expressing HLA-DR+/CD38+ | At Pre-entry, entry, Weeks 22 and 24 |
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| Secondary | Change in Total CD4 T Cell Count From Baseline to Week 12 | Baseline CD4 count (mean of pre-entry and entry CD4 count) is subtracted from the mean of week 10 and week 12 CD4 count | 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). | Median | Inter-Quartile Range | cells/mm^3 | At pre-entry, entry, weeks 10 and 12 |
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| Secondary | Number of Participants With Events Grade 3 or Higher | 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. | Analysis is based on all enrolled participants, off-ART and on-ART, who received study treatment. | Number | participants | From start of study treatment to study completion at week 28 |
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| Secondary | HIV-1 RNA Copies/mL at Study Entry for Off-ART Participants | Results reported are for HIV-1 RNA (copies/mL) at study entry for off-ART participants. | Analysis is based on all off-ART participants with HIV-1 RNA data at entry. | Median | Inter-Quartile Range | log10 copies/mL | At Entry |
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| Secondary | HIV-1 RNA Copies/mL at Weeks 12 and 24 for Off-ART Participants | Results reported are for HIV-1 RNA (copies/mL) at week 12 and week 24 for off-ART participants. | Analysis is based on all off-ART participants with HIV-1 RNA data at week 12 and week 24. | Median | Inter-Quartile Range | log10 copies/mL | At weeks 12 and 24 |
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| Secondary | HIV-1 RNA Copies/mL at Study Entry for On-ART Participants | Results reported are for HIV-1 RNA at study entry for on-ART participants. | Analysis is based on all on-ART participants with HIV-1 RNA data at entry. | Number | participants | At Entry |
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| Secondary | HIV-1 RNA Copies/mL at Week 12 for On-ART Participants | Results reported are for HIV-1 RNA at week 12 for on-ART participants. | Analysis is based on all on-ART participants with HIV-1 RNA data at week 12. | Number | participants | At week 12 |
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| Secondary | HIV-1 RNA Copies/mL at Week 24 for On-ART Participants | Results reported are for HIV-1 RNA at week 24 for on-ART participants. | Analysis is based on all on-ART participants with HIV-1 RNA data at week 24. | Number | participants | At week 24 |
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| Secondary | Percent CD8 CD38+ at Baseline | Baseline CD8 CD38+ is computed as the mean of pre-entry and entry CD8 CD38+. | Analysis is based on all participants with assay data at pre-entry or entry. | Median | Inter-Quartile Range | percent of CD8 expressing CD38+ | At pre-entry and entry |
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| Secondary | Percent CD8 CD38+ at Week 12 | Results reported are the week 12 percentage of CD8 expressing CD38+. | Analysis is based on all participants with assay data at week 12. | Median | Inter-Quartile Range | percent of CD8 expressing CD38+ | At Week 12 |
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| Secondary | Percent CD8 CD38+ at Week 24 | Results reported are the week 24 percentage of CD8 expressing CD38+. | Analysis is based on all participants with assay data at week 24. | Median | Inter-Quartile Range | percent of CD8 expressing CD38+ | At Week 24 |
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| Secondary | Percent CD4 HLA-DR+/CD38+ at Baseline | Baseline CD4 HLA-DR+/CD38+ is computed as the mean of pre-entry and entry CD4 HLA-DR+/CD38+. | Analysis is based on all participants with assay data at pre-entry or entry. | Median | Inter-Quartile Range | percent of CD4 expressing HLA-DR+/CD38+ | At pre-entry and entry |
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| Secondary | Percent CD4 HLA-DR+/CD38+ at Week 12 | Results reported are the week 12 percentage of CD4 expressing HLA-DR+/CD38+. | Analysis is based on all participants with assay data at week 12. | Median | Inter-Quartile Range | percent of CD4 expressing HLA-DR+/CD38+ | At Week 12 |
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| Secondary | Percent CD4 HLA-DR+/CD38+ at Week 24 | Results reported are the week 24 percentage of CD4 expressing HLA-DR+/CD38+. | Analysis is based on all participants with assay data at week 24. | Median | Inter-Quartile Range | percent of CD4 expressing HLA-DR+/CD38+ | At Week 24 |
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| Secondary | IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Baseline | 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. | Analysis is based on all participants with assay data at pre-entry or entry. | Median | Inter-Quartile Range | pg/mL | At pre-entry and entry |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Week 12 | Results reported are the week 12 IL-6, sTNF-rI and D-dimer. | Analysis is based on all participants with assay data at week 12. | Median | Inter-Quartile Range | pg/mL | At week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Week 24 | Results reported are the week 24 IL-6, sTNF-rI and D-dimer. | Analysis is based on all participants with assay data at week 24. | Median | Inter-Quartile Range | pg/mL | At week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Soluble CD14 (sCD14) at Baseline | Baseline sCD14 was computed as the mean of pre-entry and entry sCD14. | Analysis is based on all participants with assay data at pre-entry or entry. | Median | Inter-Quartile Range | million pg/mL | At pre-entry and entry |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Soluble CD14 (sCD14) at Week 12 | Results reported are the week 12 sCD14. | Analysis is based on all participants with assay data at week 12. | Median | Inter-Quartile Range | million pg/mL | At week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Soluble CD14 (sCD14) at Week 24 | Results reported are the week 24 sCD14. | Analysis is based on all participants with assay data at week 24. | Median | Inter-Quartile Range | million pg/mL | At week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Fasting Lipopolysaccharides (LPS) at Entry | Results reported are for entry fasting LPS. | Analysis is based on all participants with assay data at entry. | Median | Inter-Quartile Range | pg/mL | At entry |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Fasting Lipopolysaccharides (LPS) at Week 12 | Results reported are the week 12 fasting LPS. | Analysis is based on all participants with assay data at week 12. | Median | Inter-Quartile Range | pg/mL | At week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Fasting Lipopolysaccharides (LPS) at Week 24 | Results reported are the week 24 fasting LPS. | Analysis is based on all participants with assay data at week 24. | Median | Inter-Quartile Range | pg/mL | At week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Baseline | 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. | Analysis is based on all participants with assay data at pre-entry or entry. | Median | Inter-Quartile Range | percentage of cells | At pre-entry and entry |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 12 | Results reported are the week 12 percent activation levels of pDC and mDC. | Analysis is based on all participants with assay data at week 12. | Median | Inter-Quartile Range | percentage of cells | At week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 24 | Results reported are the week 24 percent activation levels of pDC and mDC. | Analysis is based on all participants with assay data at week 24. | Median | Inter-Quartile Range | percentage of cells | At week 24 |
|
AEs reported from start of study treatment until study completion at 28 weeks.
AE reporting followed DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and AEs grade 3 and higher (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 1 | 16 | 10 | 16 | ||
| EG001 | 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. | 1 | 17 | 12 | 17 | ||
| EG002 | 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. | 3 | 18 | 10 | 18 | ||
| EG003 | 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. | 1 | 19 | 7 | 19 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Abnormal behaviour | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Oculogyric crisis | Eye disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Retinal depigmentation | Eye disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Retinal pigmentation | Eye disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Anogenital dysplasia | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Acute hepatitis C | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Genitourinary chlamydia infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Hepatitis C | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Latent syphilis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Onychomycosis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Oropharyngeal candidiasis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Secondary syphilis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Vulvovaginitis trichomonal | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Blood albumin abnormal | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase abnormal | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Blood cholesterol | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Blood glucose abnormal | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Blood potassium increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Anorectal human papilloma virus infection | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Fibrous histiocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Penile wart | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Acute psychosis | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dependence | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hallucination, auditory | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hallucination, visual | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Paranoia | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Scrotal varicose veins | Reproductive system and breast disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dermatosis | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Poor personal hygiene | Social circumstances | MedDRA 17.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| ACTG Clinicaltrials.gov Coordinator | ACTG Network Coordinating Center, Social and Scientific Systems | (301) 628-3313 | ACTGCT.Gov@s-3.com |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| ID | Term |
|---|---|
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| 30-39 years |
|
| 40-49 years |
|
| 50-59 years |
|
| 60-69 years |
|
| 70-79 years |
|
| Male |
|
|
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. |
| Wilcoxon (Mann-Whitney) |
No other adjustments. |
| 0.247 |
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. |
| No |
| Superiority or Other |
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. |
| OG002 | 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. |
| OG003 | 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. |
|
|
| 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. |
| OG003 | 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. |
|
|
|
|
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. |
| OG003 | 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. |
|
|
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.
| OG003 | 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. |
|
|
|
|
|
|
|
| OG003 | 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. |
|
|
| OG003 | 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. |
|
|
| OG003 | 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. |
|
|
| OG003 | 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. |
|
|
| OG003 | 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. |
|
|
| OG003 | 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. |
|
|
| OG003 | 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. |
|
|
| OG003 | 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. |
|
|
| OG003 | 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. |
|
|
| OG003 | 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. |
|
|
| OG003 | 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. |
|
|
| OG003 | 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. |
|
|
| OG003 | 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. |
|
|
| OG003 | 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. |
|
|
| OG003 | 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. |
|
|
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. |
| OG003 | 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. |
|
|
| OG003 | 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. |
|
|
| OG003 | 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. |
|
|