HIV Infections
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGChloroquine
Taken orally, once daily, at a dose of 250 mg for 12 weeks.
DRUGPlacebo
Taken orally, once daily for 12 weeks.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* HIV-1 infected * Certain specified laboratory values obtained within 30 days prior to study entry. More information on this criterion can be found in the study protocol. * Documentation that pre-entry specimen for the primary immune activation endpoint responses has been obtained * Female participants of reproductive potential must have a negative pregnancy test performed within 24 hours prior to study entry * If engaging in sexual activity, female participants must use adequate forms of contraception while receiving study treatment and for 4 weeks after stopping the treatment. More information on this criterion can be found in the study protocol. * Ability and willingness to provide informed consent Additional Inclusion Criteria for Off-ART Participants: * No antiretroviral therapy (ART) for at least 6 months prior to study entry and not likely to start within the 6 months after study entry * CD4 cell count greater than or equal to 400 cells/mm3 at screening, obtained within 30 days prior to study entry * For participants with previous ART use, documentation or recall of nadir CD4 cell count greater than or equal to 200 cells/mm3 * HIV-1 RNA viral load greater than or equal to 1,000 copies/mL obtained within 30 days prior to study entry * No history of CDC category C AIDS-related opportunistic infections * Karnofsky performance score greater than or equal to 70 within 30 days prior to study entry Additional Inclusion Criteria for On-ART Participants: * Receiving ART, defined as a regimen that includes three or more antiretroviral medications, for at least 24 months prior to study entry * Required documentation that all HIV-1 viral loads (at least two) were below 400 copies/mL. More information on this criterion can be found in the study protocol. * Screening HIV-1 RNA \<200 copies/mL within 30 days prior to study entry. More information on this criterion can be found in the study protocol. * CD4 cell count \<350 cells/mm3 at screening, obtained within 30 days prior to study entry
Exclusion criteria
* Continuous use of certain specified medication for more than 3 days within 30 days prior to study entry. More information on this criterion can be found in the study protocol. * Use of chloroquine or hydroxychloroquine within 3 months prior to study entry * Known history of hypersensitivity to 4-aminoquinoline compounds (such as chloroquine or hydroxychloroquine) * Active drug or alcohol use or dependence that, in the opinion of the investigator would interfere with adherence to study requirements * Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to study entry * Renal insufficiency, defined as serum creatinine greater than 1.5 mg/dL, within 30 days prior to study entry * History of retinal disease (i.e. confirmed retinopathy by ophthalmologic examination) * History of neoplasm, within 5 years prior to study entry, other than treated in situ carcinoma or basal-cell or localized squamous cell carcinoma of the skin * Glucose-6-phosphate dehydrogenase (G6PD) deficiency at screening * History of porphyria * History of psoriasis * History of cirrhosis * History of seizure disorder * History of tinnitus (ear and/or head noise lasting more than 5 minutes that occurs more often than once per week) or history of sudden hearing loss * History of myopathy * History of cardiac conduction abnormality or cardiomyopathy. More information on this criterion can be found in the study protocol. Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Percent CD8 HLA-DR+/CD38+ From Baseline to Week 12 | At pre-entry, entry, weeks 10 and 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+. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent CD8 CD38+ at Week 24 | At Week 24 | Results reported are the week 24 percentage of CD8 expressing CD38+. |
| Percent CD4 HLA-DR+/CD38+ at Baseline | At pre-entry and entry | Baseline CD4 HLA-DR+/CD38+ is computed as the mean of pre-entry and entry CD4 HLA-DR+/CD38+. |
| Percent CD4 HLA-DR+/CD38+ at Week 12 | At Week 12 | Results reported are the week 12 percentage of CD4 expressing HLA-DR+/CD38+. |
| Percent CD4 HLA-DR+/CD38+ at Week 24 | At Week 24 | Results reported are the week 24 percentage of CD4 expressing HLA-DR+/CD38+. |
| IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Week 24 | At week 24 | Results reported are the week 24 IL-6, sTNF-rI and D-dimer. |
| IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Baseline | At pre-entry and entry | Baseline IL-6, sTNF-rI and D-dimer were computed as the mean of pre-entry and entry IL-6, sTNF-rI and D-dimer, respectively. |
| Change in Percent CD8 HLA-DR+/CD38+ From Start to End of the 12-week Chloroquine Treatment Period | For Arms A and C: Pre-entry, entry, weeks 10 and 12. For Arms B and D: Weeks 10, 12, 22 and 24 | 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+. |
| Change in Percent CD8 HLA-DR+/CD38+ From Week 12 to Week 24 | At Weeks 10, 12, 22 and 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+ |
| Change in Percent CD8 HLA-DR+/CD38+ From Baseline to Week 24 in Arm A and Arm C | At Pre-entry, entry, Weeks 22 and 24 | 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+. |
| Change in Total CD4 T Cell Count From Baseline to Week 12 | At pre-entry, entry, weeks 10 and 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 |
| Number of Participants With Events Grade 3 or Higher | From start of study treatment to study completion at week 28 | 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. |
| HIV-1 RNA Copies/mL at Study Entry for Off-ART Participants | At Entry | Results reported are for HIV-1 RNA (copies/mL) at study entry for off-ART participants. |
| HIV-1 RNA Copies/mL at Weeks 12 and 24 for Off-ART Participants | At weeks 12 and 24 | Results reported are for HIV-1 RNA (copies/mL) at week 12 and week 24 for off-ART participants. |
| IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Week 12 | At week 12 | Results reported are the week 12 IL-6, sTNF-rI and D-dimer. |
| HIV-1 RNA Copies/mL at Week 12 for On-ART Participants | At week 12 | Results reported are for HIV-1 RNA at week 12 for on-ART participants. |
| HIV-1 RNA Copies/mL at Week 24 for On-ART Participants | At week 24 | Results reported are for HIV-1 RNA at week 24 for on-ART participants. |
| Percent CD8 CD38+ at Baseline | At pre-entry and entry | Baseline CD8 CD38+ is computed as the mean of pre-entry and entry CD8 CD38+. |
| Percent CD8 CD38+ at Week 12 | At Week 12 | Results reported are the week 12 percentage of CD8 expressing CD38+. |
| Soluble CD14 (sCD14) at Baseline | At pre-entry and entry | Baseline sCD14 was computed as the mean of pre-entry and entry sCD14. |
| Soluble CD14 (sCD14) at Week 12 | At week 12 | Results reported are the week 12 sCD14. |
| Soluble CD14 (sCD14) at Week 24 | At week 24 | Results reported are the week 24 sCD14. |
| Fasting Lipopolysaccharides (LPS) at Entry | At entry | Results reported are for entry fasting LPS. |
| Fasting Lipopolysaccharides (LPS) at Week 12 | At week 12 | Results reported are the week 12 fasting LPS. |
| Fasting Lipopolysaccharides (LPS) at Week 24 | At week 24 | Results reported are the week 24 fasting LPS. |
| Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Baseline | At pre-entry and entry | Baseline percent activation levels of pDC were computed as the mean of pre-entry and entry percent activation levels of pDC. Similarly, baseline percent activation levels of mDC were computed as the mean of pre-entry and entry percent activation levels of mDC. |
| Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 12 | At week 12 | Results reported are the week 12 percent activation levels of pDC and mDC. |
| Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 24 | At week 24 | Results reported are the week 24 percent activation levels of pDC and mDC. |
| HIV-1 RNA Copies/mL at Study Entry for On-ART Participants | At Entry | Results reported are for HIV-1 RNA at study entry for on-ART participants. |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 16 |
| 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. | 17 |
| 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. | 18 |
| 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. | 19 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | 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 |
|---|---|---|---|---|---|
| Age, Continuous | 35 years | 39 years | 50 years | 49 years | 46 years |
| Age, Customized 18-29 years | 5 participants | 2 participants | 1 participants | 0 participants | 8 participants |
| Age, Customized 30-39 years | 5 participants | 7 participants | 1 participants | 3 participants | 16 participants |
| Age, Customized 40-49 years | 5 participants | 8 participants | 5 participants | 7 participants | 25 participants |
| Age, Customized 50-59 years | 1 participants | 0 participants | 10 participants | 7 participants | 18 participants |
| Age, Customized 60-69 years | 0 participants | 0 participants | 0 participants | 2 participants | 2 participants |
| Age, Customized 70-79 years | 0 participants | 0 participants | 1 participants | 0 participants | 1 participants |
| Region of Enrollment United States | 16 participants | 17 participants | 18 participants | 19 participants | 70 participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 1 Participants | 2 Participants | 7 Participants |
| Sex: Female, Male Male | 14 Participants | 15 Participants | 17 Participants | 17 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 10 / 16 | 12 / 17 | 10 / 18 | 7 / 19 |
| serious Total, serious adverse events | 1 / 16 | 1 / 17 | 3 / 18 | 1 / 19 |
Outcome results
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+.
Time frame: At pre-entry, entry, weeks 10 and 12
Population: Analysis used a modified as-treated approach, limited to participants with assay data at baseline and weeks 10 or 12, and with no break in study treatment for \>=14 days. Off-ART analysis excluded participants who started ART. On-ART analysis excluded participants who stopped ART or had virologic rebound (confirmed HIV-1 RNA\>1000 copies/mL).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| A: Chloroquine Then Placebo for Off-ART Participants | Change in Percent CD8 HLA-DR+/CD38+ From Baseline to Week 12 | -2.0 percent of CD8 expressing HLA-DR+/CD38+ |
| B: Placebo Then Chloroquine for Off-ART Participants | Change in Percent CD8 HLA-DR+/CD38+ From Baseline to Week 12 | -0.5 percent of CD8 expressing HLA-DR+/CD38+ |
| C: Chloroquine Then Placebo for On-ART Participants | Change in Percent CD8 HLA-DR+/CD38+ From Baseline to Week 12 | -3.1 percent of CD8 expressing HLA-DR+/CD38+ |
| D: Placebo Then Chloroquine for On-ART Participants | Change in Percent CD8 HLA-DR+/CD38+ From Baseline to Week 12 | -1.2 percent of CD8 expressing HLA-DR+/CD38+ |
Comparison: 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.p-value: 0.247Wilcoxon (Mann-Whitney)
Comparison: 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.p-value: 0.428Wilcoxon (Mann-Whitney)
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+.
Time frame: At Pre-entry, entry, Weeks 22 and 24
Population: Analysis used a modified as-treated approach, limited to participants with assay data at baseline and weeks 22 or 24, and with no break in study treatment for \>=14 days. Off-ART analysis excluded participants who started ART. On-ART analysis excluded participants who stopped ART or had virologic rebound (confirmed HIV-1 RNA\>1000 copies/mL).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| A: Chloroquine Then Placebo for Off-ART Participants | Change in Percent CD8 HLA-DR+/CD38+ From Baseline to Week 24 in Arm A and Arm C | 10.8 percent of CD8 expressing HLA-DR+/CD38+ |
| B: Placebo Then Chloroquine for Off-ART Participants | Change in Percent CD8 HLA-DR+/CD38+ From Baseline to Week 24 in Arm A and Arm C | -2.4 percent of CD8 expressing HLA-DR+/CD38+ |
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+.
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
Population: Analysis used a modified as-treated approach, limited to participants with assay data at the required time points, and with no break in study treatment for \>=14 days. Off-ART analysis excluded participants who started ART. On-ART analysis excluded participants who stopped ART or had virologic rebound (confirmed HIV-1 RNA\>1000 copies/mL).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| A: Chloroquine Then Placebo for Off-ART Participants | Change in Percent CD8 HLA-DR+/CD38+ From Start to End of the 12-week Chloroquine Treatment Period | -2.0 percent of CD8 expressing HLA-DR+/CD38+ |
| B: Placebo Then Chloroquine for Off-ART Participants | Change in Percent CD8 HLA-DR+/CD38+ From Start to End of the 12-week Chloroquine Treatment Period | 1.5 percent of CD8 expressing HLA-DR+/CD38+ |
| C: Chloroquine Then Placebo for On-ART Participants | Change in Percent CD8 HLA-DR+/CD38+ From Start to End of the 12-week Chloroquine Treatment Period | -3.1 percent of CD8 expressing HLA-DR+/CD38+ |
| D: Placebo Then Chloroquine for On-ART Participants | Change in Percent CD8 HLA-DR+/CD38+ From Start to End of the 12-week Chloroquine Treatment Period | -2.9 percent of CD8 expressing HLA-DR+/CD38+ |
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+
Time frame: At Weeks 10, 12, 22 and 24
Population: Analysis used a modified as-treated approach, limited to participants with assay data at weeks 10 or 12, and 22 or 24, and with no break in study treatment for \>=14 days. Off-ART analysis excluded participants who started ART. On-ART analysis excluded participants who stopped ART or had virologic rebound (confirmed HIV-1 RNA\>1000 copies/mL).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| A: Chloroquine Then Placebo for Off-ART Participants | Change in Percent CD8 HLA-DR+/CD38+ From Week 12 to Week 24 | 5.5 percent of CD8 expressing HLA-DR+/CD38+ |
| B: Placebo Then Chloroquine for Off-ART Participants | Change in Percent CD8 HLA-DR+/CD38+ From Week 12 to Week 24 | 1.5 percent of CD8 expressing HLA-DR+/CD38+ |
| C: Chloroquine Then Placebo for On-ART Participants | Change in Percent CD8 HLA-DR+/CD38+ From Week 12 to Week 24 | -0.1 percent of CD8 expressing HLA-DR+/CD38+ |
| D: Placebo Then Chloroquine for On-ART Participants | Change in Percent CD8 HLA-DR+/CD38+ From Week 12 to Week 24 | -2.9 percent of CD8 expressing HLA-DR+/CD38+ |
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
Time frame: At pre-entry, entry, weeks 10 and 12
Population: Analysis used a modified as-treated approach, limited to participants with assay data at baseline and weeks 10 or 12, and with no break in study treatment for \>=14 days. Off-ART analysis excluded participants who started ART. On-ART analysis excluded participants who stopped ART or had virologic rebound (confirmed HIV-1 RNA\>1000 copies/mL).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| A: Chloroquine Then Placebo for Off-ART Participants | Change in Total CD4 T Cell Count From Baseline to Week 12 | -27 cells/mm^3 |
| B: Placebo Then Chloroquine for Off-ART Participants | Change in Total CD4 T Cell Count From Baseline to Week 12 | -11 cells/mm^3 |
| C: Chloroquine Then Placebo for On-ART Participants | Change in Total CD4 T Cell Count From Baseline to Week 12 | -6 cells/mm^3 |
| D: Placebo Then Chloroquine for On-ART Participants | Change in Total CD4 T Cell Count From Baseline to Week 12 | 7 cells/mm^3 |
Secondary
Fasting Lipopolysaccharides (LPS) at Entry
Results reported are for entry fasting LPS.
Time frame: At entry
Population: Analysis is based on all participants with assay data at entry.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| A: Chloroquine Then Placebo for Off-ART Participants | Fasting Lipopolysaccharides (LPS) at Entry | 13.68 pg/mL |
| B: Placebo Then Chloroquine for Off-ART Participants | Fasting Lipopolysaccharides (LPS) at Entry | 1.64 pg/mL |
| C: Chloroquine Then Placebo for On-ART Participants | Fasting Lipopolysaccharides (LPS) at Entry | 8.00 pg/mL |
| D: Placebo Then Chloroquine for On-ART Participants | Fasting Lipopolysaccharides (LPS) at Entry | 7.00 pg/mL |
Secondary
Fasting Lipopolysaccharides (LPS) at Week 12
Results reported are the week 12 fasting LPS.
Time frame: At week 12
Population: Analysis is based on all participants with assay data at week 12.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| A: Chloroquine Then Placebo for Off-ART Participants | Fasting Lipopolysaccharides (LPS) at Week 12 | 14.37 pg/mL |
| B: Placebo Then Chloroquine for Off-ART Participants | Fasting Lipopolysaccharides (LPS) at Week 12 | 13.06 pg/mL |
| C: Chloroquine Then Placebo for On-ART Participants | Fasting Lipopolysaccharides (LPS) at Week 12 | 7.00 pg/mL |
| D: Placebo Then Chloroquine for On-ART Participants | Fasting Lipopolysaccharides (LPS) at Week 12 | 7.00 pg/mL |
Secondary
Fasting Lipopolysaccharides (LPS) at Week 24
Results reported are the week 24 fasting LPS.
Time frame: At week 24
Population: Analysis is based on all participants with assay data at week 24.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| A: Chloroquine Then Placebo for Off-ART Participants | Fasting Lipopolysaccharides (LPS) at Week 24 | 20.54 pg/mL |
| B: Placebo Then Chloroquine for Off-ART Participants | Fasting Lipopolysaccharides (LPS) at Week 24 | 2.83 pg/mL |
| C: Chloroquine Then Placebo for On-ART Participants | Fasting Lipopolysaccharides (LPS) at Week 24 | 7.00 pg/mL |
| D: Placebo Then Chloroquine for On-ART Participants | Fasting Lipopolysaccharides (LPS) at Week 24 | 8.00 pg/mL |
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.
Time frame: At Entry
Population: Analysis is based on all off-ART participants with HIV-1 RNA data at entry.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| A: Chloroquine Then Placebo for Off-ART Participants | HIV-1 RNA Copies/mL at Study Entry for Off-ART Participants | 4.48 log10 copies/mL |
| B: Placebo Then Chloroquine for Off-ART Participants | HIV-1 RNA Copies/mL at Study Entry for Off-ART Participants | 4.42 log10 copies/mL |
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.
Time frame: At Entry
Population: Analysis is based on all on-ART participants with HIV-1 RNA data at entry.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Chloroquine Then Placebo for Off-ART Participants | HIV-1 RNA Copies/mL at Study Entry for On-ART Participants | at or below lower limit of quantitation | 16 participants |
| A: Chloroquine Then Placebo for Off-ART Participants | HIV-1 RNA Copies/mL at Study Entry for On-ART Participants | above lower limit of quantitation | 2 participants |
| B: Placebo Then Chloroquine for Off-ART Participants | HIV-1 RNA Copies/mL at Study Entry for On-ART Participants | at or below lower limit of quantitation | 17 participants |
| B: Placebo Then Chloroquine for Off-ART Participants | HIV-1 RNA Copies/mL at Study Entry for On-ART Participants | above lower limit of quantitation | 2 participants |
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.
Time frame: At week 12
Population: Analysis is based on all on-ART participants with HIV-1 RNA data at week 12.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Chloroquine Then Placebo for Off-ART Participants | HIV-1 RNA Copies/mL at Week 12 for On-ART Participants | at or below lower limit of quantitation | 16 participants |
| A: Chloroquine Then Placebo for Off-ART Participants | HIV-1 RNA Copies/mL at Week 12 for On-ART Participants | above lower limit of quantitation | 1 participants |
| B: Placebo Then Chloroquine for Off-ART Participants | HIV-1 RNA Copies/mL at Week 12 for On-ART Participants | at or below lower limit of quantitation | 18 participants |
| B: Placebo Then Chloroquine for Off-ART Participants | HIV-1 RNA Copies/mL at Week 12 for On-ART Participants | above lower limit of quantitation | 1 participants |
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.
Time frame: At week 24
Population: Analysis is based on all on-ART participants with HIV-1 RNA data at week 24.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Chloroquine Then Placebo for Off-ART Participants | HIV-1 RNA Copies/mL at Week 24 for On-ART Participants | at or below lower limit of quantitation | 14 participants |
| A: Chloroquine Then Placebo for Off-ART Participants | HIV-1 RNA Copies/mL at Week 24 for On-ART Participants | above lower limit of quantitation | 2 participants |
| B: Placebo Then Chloroquine for Off-ART Participants | HIV-1 RNA Copies/mL at Week 24 for On-ART Participants | at or below lower limit of quantitation | 18 participants |
| B: Placebo Then Chloroquine for Off-ART Participants | HIV-1 RNA Copies/mL at Week 24 for On-ART Participants | above lower limit of quantitation | 1 participants |
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.
Time frame: At weeks 12 and 24
Population: Analysis is based on all off-ART participants with HIV-1 RNA data at week 12 and week 24.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| A: Chloroquine Then Placebo for Off-ART Participants | HIV-1 RNA Copies/mL at Weeks 12 and 24 for Off-ART Participants | Week 12 | 4.68 log10 copies/mL |
| A: Chloroquine Then Placebo for Off-ART Participants | HIV-1 RNA Copies/mL at Weeks 12 and 24 for Off-ART Participants | Week 24 | 4.69 log10 copies/mL |
| B: Placebo Then Chloroquine for Off-ART Participants | HIV-1 RNA Copies/mL at Weeks 12 and 24 for Off-ART Participants | Week 12 | 4.28 log10 copies/mL |
| B: Placebo Then Chloroquine for Off-ART Participants | HIV-1 RNA Copies/mL at Weeks 12 and 24 for Off-ART Participants | Week 24 | 4.61 log10 copies/mL |
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.
Time frame: At pre-entry and entry
Population: Analysis is based on all participants with assay data at pre-entry or entry.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| A: Chloroquine Then Placebo for Off-ART Participants | IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Baseline | IL-6 | 1.65 pg/mL |
| A: Chloroquine Then Placebo for Off-ART Participants | IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Baseline | D-dimer | 286390 pg/mL |
| A: Chloroquine Then Placebo for Off-ART Participants | IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Baseline | sTNF-rI | 1228.66 pg/mL |
| B: Placebo Then Chloroquine for Off-ART Participants | IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Baseline | IL-6 | 1.62 pg/mL |
| B: Placebo Then Chloroquine for Off-ART Participants | IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Baseline | D-dimer | 328460 pg/mL |
| B: Placebo Then Chloroquine for Off-ART Participants | IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Baseline | sTNF-rI | 1377.81 pg/mL |
| C: Chloroquine Then Placebo for On-ART Participants | IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Baseline | sTNF-rI | 1316.63 pg/mL |
| C: Chloroquine Then Placebo for On-ART Participants | IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Baseline | IL-6 | 1.01 pg/mL |
| C: Chloroquine Then Placebo for On-ART Participants | IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Baseline | D-dimer | 107890 pg/mL |
| D: Placebo Then Chloroquine for On-ART Participants | IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Baseline | IL-6 | 1.51 pg/mL |
| D: Placebo Then Chloroquine for On-ART Participants | IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Baseline | D-dimer | 103530 pg/mL |
| D: Placebo Then Chloroquine for On-ART Participants | IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Baseline | sTNF-rI | 1250.85 pg/mL |
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.
Time frame: At week 12
Population: Analysis is based on all participants with assay data at week 12.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| A: Chloroquine Then Placebo for Off-ART Participants | IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Week 12 | IL-6 | 1.68 pg/mL |
| A: Chloroquine Then Placebo for Off-ART Participants | IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Week 12 | D-dimer | 251320 pg/mL |
| A: Chloroquine Then Placebo for Off-ART Participants | IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Week 12 | sTNF-rI | 1209.50 pg/mL |
| B: Placebo Then Chloroquine for Off-ART Participants | IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Week 12 | D-dimer | 319770 pg/mL |
| B: Placebo Then Chloroquine for Off-ART Participants | IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Week 12 | sTNF-rI | 1347.06 pg/mL |
| B: Placebo Then Chloroquine for Off-ART Participants | IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Week 12 | IL-6 | 1.28 pg/mL |
| C: Chloroquine Then Placebo for On-ART Participants | IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Week 12 | sTNF-rI | 1441.35 pg/mL |
| C: Chloroquine Then Placebo for On-ART Participants | IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Week 12 | D-dimer | 126540 pg/mL |
| C: Chloroquine Then Placebo for On-ART Participants | IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Week 12 | IL-6 | 1.15 pg/mL |
| D: Placebo Then Chloroquine for On-ART Participants | IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Week 12 | D-dimer | 117890 pg/mL |
| D: Placebo Then Chloroquine for On-ART Participants | IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Week 12 | IL-6 | 1.30 pg/mL |
| D: Placebo Then Chloroquine for On-ART Participants | IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Week 12 | sTNF-rI | 1304.77 pg/mL |
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.
Time frame: At week 24
Population: Analysis is based on all participants with assay data at week 24.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| A: Chloroquine Then Placebo for Off-ART Participants | IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Week 24 | IL-6 | 1.34 pg/mL |
| A: Chloroquine Then Placebo for Off-ART Participants | IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Week 24 | D-dimer | 264240 pg/mL |
| A: Chloroquine Then Placebo for Off-ART Participants | IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Week 24 | sTNF-rI | 1327.21 pg/mL |
| B: Placebo Then Chloroquine for Off-ART Participants | IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Week 24 | IL-6 | 1.18 pg/mL |
| B: Placebo Then Chloroquine for Off-ART Participants | IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Week 24 | D-dimer | 294780 pg/mL |
| B: Placebo Then Chloroquine for Off-ART Participants | IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Week 24 | sTNF-rI | 1420.30 pg/mL |
| C: Chloroquine Then Placebo for On-ART Participants | IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Week 24 | sTNF-rI | 1230.21 pg/mL |
| C: Chloroquine Then Placebo for On-ART Participants | IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Week 24 | IL-6 | 1.02 pg/mL |
| C: Chloroquine Then Placebo for On-ART Participants | IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Week 24 | D-dimer | 100860 pg/mL |
| D: Placebo Then Chloroquine for On-ART Participants | IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Week 24 | IL-6 | 1.27 pg/mL |
| D: Placebo Then Chloroquine for On-ART Participants | IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Week 24 | D-dimer | 124920 pg/mL |
| D: Placebo Then Chloroquine for On-ART Participants | IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Week 24 | sTNF-rI | 1176.20 pg/mL |
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.
Time frame: From start of study treatment to study completion at week 28
Population: Analysis is based on all enrolled participants, off-ART and on-ART, who received study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| A: Chloroquine Then Placebo for Off-ART Participants | Number of Participants With Events Grade 3 or Higher | 0 participants |
| B: Placebo Then Chloroquine for Off-ART Participants | Number of Participants With Events Grade 3 or Higher | 1 participants |
| C: Chloroquine Then Placebo for On-ART Participants | Number of Participants With Events Grade 3 or Higher | 1 participants |
| D: Placebo Then Chloroquine for On-ART Participants | Number of Participants With Events Grade 3 or Higher | 0 participants |
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.
Time frame: At pre-entry and entry
Population: Analysis is based on all participants with assay data at pre-entry or entry.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| A: Chloroquine Then Placebo for Off-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Baseline | %pDC expressing CD80+ | 0.03 percentage of cells |
| A: Chloroquine Then Placebo for Off-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Baseline | %pDC expressing CD83+ | 45.48 percentage of cells |
| A: Chloroquine Then Placebo for Off-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Baseline | %pDC expressing CD86+ | 9.12 percentage of cells |
| A: Chloroquine Then Placebo for Off-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Baseline | %pDC expressing PDL-1+ | 2.52 percentage of cells |
| A: Chloroquine Then Placebo for Off-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Baseline | %mDC expressing CD80+ | 1.04 percentage of cells |
| A: Chloroquine Then Placebo for Off-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Baseline | %mDC expressing CD83+ | 38.60 percentage of cells |
| A: Chloroquine Then Placebo for Off-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Baseline | %mDC expressing CD86+ | 96.29 percentage of cells |
| A: Chloroquine Then Placebo for Off-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Baseline | %mDC expressing PDL-1+ | 9.82 percentage of cells |
| B: Placebo Then Chloroquine for Off-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Baseline | %pDC expressing CD86+ | 9.35 percentage of cells |
| B: Placebo Then Chloroquine for Off-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Baseline | %mDC expressing CD80+ | 0.83 percentage of cells |
| B: Placebo Then Chloroquine for Off-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Baseline | %mDC expressing PDL-1+ | 16.37 percentage of cells |
| B: Placebo Then Chloroquine for Off-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Baseline | %pDC expressing CD83+ | 36.15 percentage of cells |
| B: Placebo Then Chloroquine for Off-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Baseline | %pDC expressing PDL-1+ | 6.13 percentage of cells |
| B: Placebo Then Chloroquine for Off-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Baseline | %pDC expressing CD80+ | 0.03 percentage of cells |
| B: Placebo Then Chloroquine for Off-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Baseline | %mDC expressing CD83+ | 39.94 percentage of cells |
| B: Placebo Then Chloroquine for Off-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Baseline | %mDC expressing CD86+ | 97.52 percentage of cells |
| C: Chloroquine Then Placebo for On-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Baseline | %mDC expressing CD83+ | 48.17 percentage of cells |
| C: Chloroquine Then Placebo for On-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Baseline | %pDC expressing CD80+ | 0.13 percentage of cells |
| C: Chloroquine Then Placebo for On-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Baseline | %pDC expressing CD86+ | 10.96 percentage of cells |
| C: Chloroquine Then Placebo for On-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Baseline | %pDC expressing CD83+ | 19.91 percentage of cells |
| C: Chloroquine Then Placebo for On-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Baseline | %mDC expressing CD86+ | 96.11 percentage of cells |
| C: Chloroquine Then Placebo for On-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Baseline | %mDC expressing CD80+ | 1.31 percentage of cells |
| C: Chloroquine Then Placebo for On-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Baseline | %mDC expressing PDL-1+ | 4.58 percentage of cells |
| C: Chloroquine Then Placebo for On-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Baseline | %pDC expressing PDL-1+ | 4.48 percentage of cells |
| D: Placebo Then Chloroquine for On-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Baseline | %pDC expressing CD83+ | 23.65 percentage of cells |
| D: Placebo Then Chloroquine for On-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Baseline | %pDC expressing CD86+ | 12.66 percentage of cells |
| D: Placebo Then Chloroquine for On-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Baseline | %pDC expressing PDL-1+ | 6.49 percentage of cells |
| D: Placebo Then Chloroquine for On-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Baseline | %mDC expressing CD86+ | 95.38 percentage of cells |
| D: Placebo Then Chloroquine for On-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Baseline | %mDC expressing PDL-1+ | 8.28 percentage of cells |
| D: Placebo Then Chloroquine for On-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Baseline | %mDC expressing CD80+ | 1.17 percentage of cells |
| D: Placebo Then Chloroquine for On-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Baseline | %mDC expressing CD83+ | 26.08 percentage of cells |
| D: Placebo Then Chloroquine for On-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Baseline | %pDC expressing CD80+ | 0.07 percentage of cells |
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.
Time frame: At week 12
Population: Analysis is based on all participants with assay data at week 12.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| A: Chloroquine Then Placebo for Off-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 12 | %pDC expressing CD80+ | 0.00 percentage of cells |
| A: Chloroquine Then Placebo for Off-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 12 | %pDC expressing CD83+ | 51.90 percentage of cells |
| A: Chloroquine Then Placebo for Off-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 12 | %pDC expressing CD86+ | 7.66 percentage of cells |
| A: Chloroquine Then Placebo for Off-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 12 | %pDC expressing PDL-1+ | 3.74 percentage of cells |
| A: Chloroquine Then Placebo for Off-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 12 | %mDC expressing CD80+ | 0.84 percentage of cells |
| A: Chloroquine Then Placebo for Off-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 12 | %mDC expressing CD83+ | 43.51 percentage of cells |
| A: Chloroquine Then Placebo for Off-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 12 | %mDC expressing CD86+ | 97.90 percentage of cells |
| A: Chloroquine Then Placebo for Off-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 12 | %mDC expressing PDL-1+ | 15.03 percentage of cells |
| B: Placebo Then Chloroquine for Off-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 12 | %mDC expressing CD83+ | 36.47 percentage of cells |
| B: Placebo Then Chloroquine for Off-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 12 | %mDC expressing CD80+ | 1.03 percentage of cells |
| B: Placebo Then Chloroquine for Off-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 12 | %pDC expressing CD83+ | 40.49 percentage of cells |
| B: Placebo Then Chloroquine for Off-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 12 | %mDC expressing PDL-1+ | 16.32 percentage of cells |
| B: Placebo Then Chloroquine for Off-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 12 | %mDC expressing CD86+ | 97.18 percentage of cells |
| B: Placebo Then Chloroquine for Off-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 12 | %pDC expressing PDL-1+ | 8.43 percentage of cells |
| B: Placebo Then Chloroquine for Off-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 12 | %pDC expressing CD86+ | 8.48 percentage of cells |
| B: Placebo Then Chloroquine for Off-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 12 | %pDC expressing CD80+ | 0.05 percentage of cells |
| C: Chloroquine Then Placebo for On-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 12 | %mDC expressing CD86+ | 95.40 percentage of cells |
| C: Chloroquine Then Placebo for On-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 12 | %pDC expressing CD86+ | 13.93 percentage of cells |
| C: Chloroquine Then Placebo for On-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 12 | %pDC expressing PDL-1+ | 7.24 percentage of cells |
| C: Chloroquine Then Placebo for On-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 12 | %mDC expressing CD80+ | 1.47 percentage of cells |
| C: Chloroquine Then Placebo for On-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 12 | %mDC expressing CD83+ | 47.83 percentage of cells |
| C: Chloroquine Then Placebo for On-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 12 | %mDC expressing PDL-1+ | 7.10 percentage of cells |
| C: Chloroquine Then Placebo for On-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 12 | %pDC expressing CD80+ | 0.10 percentage of cells |
| C: Chloroquine Then Placebo for On-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 12 | %pDC expressing CD83+ | 14.70 percentage of cells |
| D: Placebo Then Chloroquine for On-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 12 | %pDC expressing CD86+ | 13.64 percentage of cells |
| D: Placebo Then Chloroquine for On-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 12 | %pDC expressing PDL-1+ | 5.16 percentage of cells |
| D: Placebo Then Chloroquine for On-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 12 | %pDC expressing CD83+ | 18.20 percentage of cells |
| D: Placebo Then Chloroquine for On-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 12 | %pDC expressing CD80+ | 0.14 percentage of cells |
| D: Placebo Then Chloroquine for On-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 12 | %mDC expressing CD80+ | 1.01 percentage of cells |
| D: Placebo Then Chloroquine for On-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 12 | %mDC expressing PDL-1+ | 6.09 percentage of cells |
| D: Placebo Then Chloroquine for On-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 12 | %mDC expressing CD86+ | 95.15 percentage of cells |
| D: Placebo Then Chloroquine for On-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 12 | %mDC expressing CD83+ | 26.75 percentage of cells |
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.
Time frame: At week 24
Population: Analysis is based on all participants with assay data at week 24.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| A: Chloroquine Then Placebo for Off-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 24 | %mDC expressing CD80+ | 0.94 percentage of cells |
| A: Chloroquine Then Placebo for Off-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 24 | %pDC expressing CD83+ | 44.50 percentage of cells |
| A: Chloroquine Then Placebo for Off-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 24 | %mDC expressing CD83+ | 41.21 percentage of cells |
| A: Chloroquine Then Placebo for Off-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 24 | %pDC expressing PDL-1+ | 4.34 percentage of cells |
| A: Chloroquine Then Placebo for Off-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 24 | %pDC expressing CD80+ | 0.05 percentage of cells |
| A: Chloroquine Then Placebo for Off-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 24 | %mDC expressing PDL-1+ | 9.53 percentage of cells |
| A: Chloroquine Then Placebo for Off-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 24 | %mDC expressing CD86+ | 97.70 percentage of cells |
| A: Chloroquine Then Placebo for Off-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 24 | %pDC expressing CD86+ | 10.13 percentage of cells |
| B: Placebo Then Chloroquine for Off-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 24 | %pDC expressing CD80+ | 0.00 percentage of cells |
| B: Placebo Then Chloroquine for Off-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 24 | %mDC expressing CD86+ | 97.05 percentage of cells |
| B: Placebo Then Chloroquine for Off-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 24 | %mDC expressing PDL-1+ | 14.84 percentage of cells |
| B: Placebo Then Chloroquine for Off-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 24 | %pDC expressing CD83+ | 38.96 percentage of cells |
| B: Placebo Then Chloroquine for Off-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 24 | %pDC expressing CD86+ | 7.89 percentage of cells |
| B: Placebo Then Chloroquine for Off-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 24 | %pDC expressing PDL-1+ | 7.45 percentage of cells |
| B: Placebo Then Chloroquine for Off-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 24 | %mDC expressing CD80+ | 1.12 percentage of cells |
| B: Placebo Then Chloroquine for Off-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 24 | %mDC expressing CD83+ | 33.19 percentage of cells |
| C: Chloroquine Then Placebo for On-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 24 | %mDC expressing PDL-1+ | 4.13 percentage of cells |
| C: Chloroquine Then Placebo for On-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 24 | %pDC expressing CD86+ | 11.79 percentage of cells |
| C: Chloroquine Then Placebo for On-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 24 | %mDC expressing CD83+ | 36.65 percentage of cells |
| C: Chloroquine Then Placebo for On-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 24 | %mDC expressing CD80+ | 0.76 percentage of cells |
| C: Chloroquine Then Placebo for On-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 24 | %pDC expressing CD80+ | 0.08 percentage of cells |
| C: Chloroquine Then Placebo for On-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 24 | %pDC expressing CD83+ | 14.80 percentage of cells |
| C: Chloroquine Then Placebo for On-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 24 | %mDC expressing CD86+ | 96.69 percentage of cells |
| C: Chloroquine Then Placebo for On-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 24 | %pDC expressing PDL-1+ | 5.63 percentage of cells |
| D: Placebo Then Chloroquine for On-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 24 | %mDC expressing PDL-1+ | 7.49 percentage of cells |
| D: Placebo Then Chloroquine for On-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 24 | %pDC expressing CD86+ | 12.88 percentage of cells |
| D: Placebo Then Chloroquine for On-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 24 | %pDC expressing CD80+ | 0.16 percentage of cells |
| D: Placebo Then Chloroquine for On-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 24 | %pDC expressing CD83+ | 17.65 percentage of cells |
| D: Placebo Then Chloroquine for On-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 24 | %pDC expressing PDL-1+ | 6.52 percentage of cells |
| D: Placebo Then Chloroquine for On-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 24 | %mDC expressing CD80+ | 1.39 percentage of cells |
| D: Placebo Then Chloroquine for On-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 24 | %mDC expressing CD83+ | 24.14 percentage of cells |
| D: Placebo Then Chloroquine for On-ART Participants | Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 24 | %mDC expressing CD86+ | 92.41 percentage of cells |
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+.
Time frame: At pre-entry and entry
Population: Analysis is based on all participants with assay data at pre-entry or entry.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| A: Chloroquine Then Placebo for Off-ART Participants | Percent CD4 HLA-DR+/CD38+ at Baseline | 8.5 percent of CD4 expressing HLA-DR+/CD38+ |
| B: Placebo Then Chloroquine for Off-ART Participants | Percent CD4 HLA-DR+/CD38+ at Baseline | 9.8 percent of CD4 expressing HLA-DR+/CD38+ |
| C: Chloroquine Then Placebo for On-ART Participants | Percent CD4 HLA-DR+/CD38+ at Baseline | 8.7 percent of CD4 expressing HLA-DR+/CD38+ |
| D: Placebo Then Chloroquine for On-ART Participants | Percent CD4 HLA-DR+/CD38+ at Baseline | 9.9 percent of CD4 expressing HLA-DR+/CD38+ |
Secondary
Percent CD4 HLA-DR+/CD38+ at Week 12
Results reported are the week 12 percentage of CD4 expressing HLA-DR+/CD38+.
Time frame: At Week 12
Population: Analysis is based on all participants with assay data at week 12.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| A: Chloroquine Then Placebo for Off-ART Participants | Percent CD4 HLA-DR+/CD38+ at Week 12 | 6.5 percent of CD4 expressing HLA-DR+/CD38+ |
| B: Placebo Then Chloroquine for Off-ART Participants | Percent CD4 HLA-DR+/CD38+ at Week 12 | 10.5 percent of CD4 expressing HLA-DR+/CD38+ |
| C: Chloroquine Then Placebo for On-ART Participants | Percent CD4 HLA-DR+/CD38+ at Week 12 | 7.7 percent of CD4 expressing HLA-DR+/CD38+ |
| D: Placebo Then Chloroquine for On-ART Participants | Percent CD4 HLA-DR+/CD38+ at Week 12 | 9.0 percent of CD4 expressing HLA-DR+/CD38+ |
Secondary
Percent CD4 HLA-DR+/CD38+ at Week 24
Results reported are the week 24 percentage of CD4 expressing HLA-DR+/CD38+.
Time frame: At Week 24
Population: Analysis is based on all participants with assay data at week 24.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| A: Chloroquine Then Placebo for Off-ART Participants | Percent CD4 HLA-DR+/CD38+ at Week 24 | 11.0 percent of CD4 expressing HLA-DR+/CD38+ |
| B: Placebo Then Chloroquine for Off-ART Participants | Percent CD4 HLA-DR+/CD38+ at Week 24 | 12.5 percent of CD4 expressing HLA-DR+/CD38+ |
| C: Chloroquine Then Placebo for On-ART Participants | Percent CD4 HLA-DR+/CD38+ at Week 24 | 7.3 percent of CD4 expressing HLA-DR+/CD38+ |
| D: Placebo Then Chloroquine for On-ART Participants | Percent CD4 HLA-DR+/CD38+ at Week 24 | 9.2 percent of CD4 expressing HLA-DR+/CD38+ |
Secondary
Percent CD8 CD38+ at Baseline
Baseline CD8 CD38+ is computed as the mean of pre-entry and entry CD8 CD38+.
Time frame: At pre-entry and entry
Population: Analysis is based on all participants with assay data at pre-entry or entry.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| A: Chloroquine Then Placebo for Off-ART Participants | Percent CD8 CD38+ at Baseline | 71.0 percent of CD8 expressing CD38+ |
| B: Placebo Then Chloroquine for Off-ART Participants | Percent CD8 CD38+ at Baseline | 77.0 percent of CD8 expressing CD38+ |
| C: Chloroquine Then Placebo for On-ART Participants | Percent CD8 CD38+ at Baseline | 50.8 percent of CD8 expressing CD38+ |
| D: Placebo Then Chloroquine for On-ART Participants | Percent CD8 CD38+ at Baseline | 49.9 percent of CD8 expressing CD38+ |
Secondary
Percent CD8 CD38+ at Week 12
Results reported are the week 12 percentage of CD8 expressing CD38+.
Time frame: At Week 12
Population: Analysis is based on all participants with assay data at week 12.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| A: Chloroquine Then Placebo for Off-ART Participants | Percent CD8 CD38+ at Week 12 | 71.5 percent of CD8 expressing CD38+ |
| B: Placebo Then Chloroquine for Off-ART Participants | Percent CD8 CD38+ at Week 12 | 79.5 percent of CD8 expressing CD38+ |
| C: Chloroquine Then Placebo for On-ART Participants | Percent CD8 CD38+ at Week 12 | 50.9 percent of CD8 expressing CD38+ |
| D: Placebo Then Chloroquine for On-ART Participants | Percent CD8 CD38+ at Week 12 | 51.9 percent of CD8 expressing CD38+ |
Secondary
Percent CD8 CD38+ at Week 24
Results reported are the week 24 percentage of CD8 expressing CD38+.
Time frame: At Week 24
Population: Analysis is based on all participants with assay data at week 24.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| A: Chloroquine Then Placebo for Off-ART Participants | Percent CD8 CD38+ at Week 24 | 78.0 percent of CD8 expressing CD38+ |
| B: Placebo Then Chloroquine for Off-ART Participants | Percent CD8 CD38+ at Week 24 | 79.5 percent of CD8 expressing CD38+ |
| C: Chloroquine Then Placebo for On-ART Participants | Percent CD8 CD38+ at Week 24 | 50.6 percent of CD8 expressing CD38+ |
| D: Placebo Then Chloroquine for On-ART Participants | Percent CD8 CD38+ at Week 24 | 48.7 percent of CD8 expressing CD38+ |
Secondary
Soluble CD14 (sCD14) at Baseline
Baseline sCD14 was computed as the mean of pre-entry and entry sCD14.
Time frame: At pre-entry and entry
Population: Analysis is based on all participants with assay data at pre-entry or entry.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| A: Chloroquine Then Placebo for Off-ART Participants | Soluble CD14 (sCD14) at Baseline | 1.43 million pg/mL |
| B: Placebo Then Chloroquine for Off-ART Participants | Soluble CD14 (sCD14) at Baseline | 1.97 million pg/mL |
| C: Chloroquine Then Placebo for On-ART Participants | Soluble CD14 (sCD14) at Baseline | 1.80 million pg/mL |
| D: Placebo Then Chloroquine for On-ART Participants | Soluble CD14 (sCD14) at Baseline | 1.58 million pg/mL |
Secondary
Soluble CD14 (sCD14) at Week 12
Results reported are the week 12 sCD14.
Time frame: At week 12
Population: Analysis is based on all participants with assay data at week 12.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| A: Chloroquine Then Placebo for Off-ART Participants | Soluble CD14 (sCD14) at Week 12 | 1.53 million pg/mL |
| B: Placebo Then Chloroquine for Off-ART Participants | Soluble CD14 (sCD14) at Week 12 | 1.88 million pg/mL |
| C: Chloroquine Then Placebo for On-ART Participants | Soluble CD14 (sCD14) at Week 12 | 2.04 million pg/mL |
| D: Placebo Then Chloroquine for On-ART Participants | Soluble CD14 (sCD14) at Week 12 | 1.63 million pg/mL |
Secondary
Soluble CD14 (sCD14) at Week 24
Results reported are the week 24 sCD14.
Time frame: At week 24
Population: Analysis is based on all participants with assay data at week 24.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| A: Chloroquine Then Placebo for Off-ART Participants | Soluble CD14 (sCD14) at Week 24 | 1.53 million pg/mL |
| B: Placebo Then Chloroquine for Off-ART Participants | Soluble CD14 (sCD14) at Week 24 | 2.19 million pg/mL |
| C: Chloroquine Then Placebo for On-ART Participants | Soluble CD14 (sCD14) at Week 24 | 1.77 million pg/mL |
| D: Placebo Then Chloroquine for On-ART Participants | Soluble CD14 (sCD14) at Week 24 | 1.72 million pg/mL |