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

Completed · Not applicable

Conditions studied: HIV-1 Infection

In brief

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).

Key facts

Study ID

NCT01286259

Run by

University of California, San Francisco

People needed

16

Starts

2011-01-01

Expected to finish

2014-05-01

Last updated by the study team

2020-06-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• San Francisco General Hospital — San Francisco, California, United States
• Johns Hopkins University — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.