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

Information source: University of California, San Francisco
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV-1 Infection

Intervention: Disulfiram (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of California, San Francisco

Official(s) and/or principal investigator(s):
Steven G. Deeks, M.D., Principal Investigator, Affiliation: University of California, San Francisco
Adriana Andrade, M.D., Principal Investigator, Affiliation: Johns Hopkins University

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).

Clinical Details

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome:

To determine if the addition of disulfiram to a stable antiretroviral regimen for two weeks results in decline in the size of the HIV-1 reservoir, as defined by the frequency of resting CD4+ T cells harboring replication competent HIV-1.

To determine if the addition of disulfiram to a stable antiretroviral regimen for two weeks is associated with an immediate or transient increase in plasma HIV-1 RNA levels.

To determine if the addition of disulfiram to a stable antiretroviral regimen for two weeks is safe and well tolerated.

To determine if the addition of disulfiram to a stable antiretroviral regimen for two weeks results in an increase in the frequency of activated CD4+ and CD8+ T cells in peripheral blood.

Detailed description: This study is using a new approach to try and force HIV out of its protected cellular reservoirs. Although current therapies are effective at "killing" new viruses that are produced, they are unable to access the virus in cells which were infected before antiretroviral therapy began. HIV can remain "hidden" in a latent (or resting) form in these cells for many years. Since these infected cells can live for many years, they are thought to be the most important barrier to HIV eradication (or "cure"). Many experts believe that one way to attack latent or "hidden" HIV is to use a drug than can "turn on" the virus and hence force HIV-1 out of resting T cells. In a recent study done in the laboratory, disulfiram proved to be among the most effective drugs currently available that can reactivate latent HIV-1, Our primary hypothesis is that disulfiram will reduce the latent reservoir of HIV-1 in patients on highly active antiretroviral therapy (HAART). Theoretically, disulfiram will force HIV to replicate (grow) and thus result in the death of the infected cell. Standard antiretroviral drugs should prevent new cells from becoming infected. The end result of this process is that the total amount of HIV in the body will decline over time.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

San Francisco General Hospital, San Francisco, California 94110, United States

Johns Hopkins University, Baltimore, Maryland 21205, United States

Additional Information

Starting date: January 2011
Last updated: October 28, 2014

Page last updated: August 20, 2015

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