Short-term Disulfiram Administration to Accelerate the Decay of the HIV Reservoir in Antiretroviral-treated HIV Infected Individuals
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University of California, San Francisco.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
University of California, San Francisco
Collaborator:
Johns Hopkins University
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01286259
First received: January 27, 2011
Last updated: March 22, 2011
Last verified: March 2011
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Purpose
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).
| Condition | Intervention |
|---|---|
|
HIV-1 Infection |
Drug: Disulfiram |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Short-term Disulfiram Administration to Accelerate the Decay of the HIV Reservoir in Antiretroviral-treated HIV Infected Individuals |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Disulfiram
U.S. FDA Resources
Further study details as provided by University of California, San Francisco:
Primary Outcome Measures:
- 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. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- 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. [ Time Frame: Two weeks ] [ Designated as safety issue: Yes ]Real time viral load will be measured weekly during the treatment phase.
- To determine if the addition of disulfiram to a stable antiretroviral regimen for two weeks is safe and well tolerated. [ Time Frame: Two weeks ] [ Designated as safety issue: Yes ]
- 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. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: Disulfiram
Open label 500mg disulfiram per day by mouth for 14 days
Other Name: Antabuse
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01286259
Locations
| United States, California | |
| San Francisco General Hospital | |
| San Francisco, California, United States, 94110 | |
| United States, Maryland | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21205 | |
Sponsors and Collaborators
University of California, San Francisco
Johns Hopkins University
Investigators
| Principal Investigator: | Steven G. Deeks, M.D. | University of California, San Francisco |
| Principal Investigator: | Adriana Andrade, M.D. | Johns Hopkins University |
More Information
No publications provided
| Responsible Party: | Steven G. Deeks, M.D./Principal Investigator, University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT01286259 History of Changes |
| Other Study ID Numbers: | IRB 10-02648 |
| Study First Received: | January 27, 2011 |
| Last Updated: | March 22, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, San Francisco:
|
HIV HAART suppressed Disulfiram Antabuse |
Latent reservoir Eradication Cure |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes |
Immune System Diseases Disulfiram Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Alcohol Deterrents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013