Short-term Disulfiram Administration to Accelerate the Decay of the HIV Reservoir in Antiretroviral-treated HIV Infected Individuals

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether a two-week course of disulfiram will reduce the HIV-1 latent reservoir in patients on highly active antiretroviral therapy (HAART).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: Johns Hopkins University
• Treatments: Disulfiram

Criteria

Inclusion Criteria:

• Documented continuous HAART for at least 18 months prior to study entry and on a stable regimen for at least 3 months prior to entry.

• Documented undetectable HIV viral loads for at least one year. Intermittent isolated episodes of detectable low-level viremia "blips" (> 50 but < 500 copies RNA/mL) remain eligible.

• Screening plasma HIV-1 RNA levels < 40 copies RNA/mL.

• CD4 T-cell count above 200 cells/uL for 24 weeks prior to screen.

• >90% adherence to therapy within the preceding 30 days.

• Females of childbearing potential must have a negative serum pregnancy test at screening and agree to use a double-barrier method of contraception throughout the study period.

• Willing to abstain from any alcohol during the two week period in which disulfiram will be administered and during the two week period immediately after disulfiram administration.

Exclusion Criteria:

• Current alcohol use disorder or hazardous alcohol use as determined by clinical evaluation.

• Current use of any drug formulation that contains alcohol or that might contain alcohol.

• Current use of tipranavir.

• Current use of maraviroc.

• Current use of warfarin.

• Intending to modify antiretroviral therapy in the next 27 weeks for any reason.

• Serious illness requiring hospitalization or parental antibiotics within preceding 3 months.

• Severe myocardial disease or coronary artery disease.

• History of psychosis.

• Clinically active hepatitis determined by the study physician; ALT or AST >3 x the upper limit of normal.

• Concurrent treatment with immunomodulatory drugs, or exposure to any immunomodulatory drug in past 16 weeks.

• Pregnant or breastfeeding women.