N/A
Completed N=16
Short-term Disulfiram Administration to Accelerate the Decay of the HIV Reservoir in Antiretroviral-treated HIV Infected Individuals
Source: ClinicalTrials.gov NCT01286259 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcomePrimary: Impact of Two Weeks of Disulfiram, as Measured by the Fold Change in the Infectious Units Per Million Cells (IUPM) Between Baseline and Week 12 — 1.16 Fold change in IUPM
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Impact of Two Weeks of Disulfiram, as Measured by the Fold Change in the Infectious Units Per Million Cells (IUPM) Between Baseline and Week 12 |
1.16 | — |
| PRIMARY Number of Participants With Adverse Events |
— | — |
| PRIMARY The Fold Change in Mean Levels of Viremia During and After Disulfiram Dosing as Compared to Baseline Levels |
1.5 | — |
| PRIMARY Number of Participants With Detectable Plasma HIV RNA |
1 | — |
Eligibility 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 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.
Data sourced from ClinicalTrials.gov (NCT01286259). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.