Chloroquine for Reducing Immune Activation in HIV- Infected Individuals

This is an interventional treatment trial for HIV Infections Read More

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 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)