Disulfiram Interactions With HIV Medications: Clinical Implications
Tracking Information | |||||
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First Received Date ICMJE | April 7, 2009 | ||||
Last Updated Date | June 14, 2012 | ||||
Start Date ICMJE | November 2008 | ||||
Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
The effect of disulfiram on the pharmacokinetics of each of the antiretroviral medications to be studied [ Time Frame: Measured at Day 15 ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00878306 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Disulfiram Interactions With HIV Medications: Clinical Implications | ||||
Official Title ICMJE | Disulfiram Interactions With HIV Medications: Clinical Implications | ||||
Brief Summary | The purpose of this study is to determine whether disulfiram might be a safe and effective treatment for cocaine and/or alcohol dependence in patients with HIV disease. This research is designed to characterize the presence or absence of significant drug interactions between disulfiram and HIV medications using standard clinical pharmacology techniques as well as monitor any side effects that might occur when these medications are administered together. |
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Detailed Description | Cocaine and alcohol abuse are strongly linked to HIV infection and transmission of the virus. Disulfiram has long been approved by the US FDA for the treatment of alcohol and recent data shows it to be effective in reducing cocaine abuse. Disulfiram and antiretroviral medications (ARV) are metabolized by cytochrome P450 3A and concomitant use of these drugs could potentially produce adverse drug interactions underscoring the need to identify and understand the clinical implications of these drug interactions in order to more effectively treat individuals with both HIV disease and cocaine and/or alcohol use disorders. This will be accomplished by conducting studies aimed at identifying whether pharmacokinetic or pharmacodynamic drug interactions of importance occur between disulfiram and medications frequently utilized in those with HIV/AIDS. Abuse of cocaine and/or alcohol has been shown to be a significant risk factor for HIV infections as a result of high risk sexual and drug use behaviors occurring in the context of use of these substances. Those with HIV infection and untreated cocaine and/or alcohol dependence are also at a high risk of transmitting HIV to others. Moreover, those with HIV disease and substance dependence often experience poor clinical outcomes as a result of nonadherence to HIV treatment regimens. Disulfiram (DIS) is an inhibitor of ALDH and has been reported to alter hepatic cytochrome P450 enzyme function important to metabolism of many drugs frequently used in the treatment of HIV/AIDS. Although approved for the treatment of alcohol dependence, DIS has been studied as a treatment for cocaine addiction in recent years. DIS at the standard 250 mg daily dose has been associated with significant reductions in cocaine use as well as alcohol use in those with histories of concomitant cocaine-alcohol abuse. DIS 250 mg daily has been shown to have a significant pharmacokinetic interaction with cocaine resulting in delayed cocaine clearance. In order to more fully access possible use of DIS treatment for cocaine and/or alcohol dependence in this population, it is important to determine if any excess risk is conveyed as a result of drug interactions that might occur between DIS and the ARV medications. This study will be using a standard clinical pharmacology study design using a within-subject design examining the two drug interaction studies between DIS (250 mg daily) and the following medications:
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Study Type ICMJE | Interventional | ||||
Study Phase | |||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE | 40 | ||||
Estimated Completion Date | December 2013 | ||||
Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00878306 | ||||
Other Study ID Numbers ICMJE | R01DA024982, R01DA 024982 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | University of California, San Francisco | ||||
Study Sponsor ICMJE | University of California, San Francisco | ||||
Collaborators ICMJE | National Institute on Drug Abuse (NIDA) | ||||
Investigators ICMJE |
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Information Provided By | University of California, San Francisco | ||||
Verification Date | June 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |