Disulfiram Interactions With HIV Medications: Clinical Implications

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Atazanavir Sulfate; Disulfiram; Efavirenz; Ritonavir

Criteria

Inclusion Criteria:

• Good health and without clinical findings that require medical or psychiatric intervention as determined by a physical and mental status examination and screening laboratory tests, urinalysis, and ECG

• 18 years of age or older

• Willing to abstain from alcohol during the study and for two weeks afterward

Exclusion Criteria:

• Patients who are receiving concurrently other drugs that are inducers or inhibitors of hepatic microsomal enzymes

• Patients with a known sensitivity to the HIV therapeutics to be studied

• Pregnant or nursing mothers

• Current major affective or psychotic illnesses or suicidality

• Clinically active hepatitis

• Diabetes, hyperlipidemia, coagulation disorders, or renal disease will be excluded

• Those meeting criteria for current alcohol or drug dependence (other than nicotine)

• HIV infection