Disulfiram Interactions With HIV Medications: Clinical Implications

• Register: ClinicalTrials.gov
• Last refreshed on: 29 April 2013
• Main ID: NCT00878306
• Date of registration: 07/04/2009
• Primary sponsor: University of California, San Francisco
• Public title: Disulfiram Interactions With HIV Medications: Clinical Implications
• Scientific title: Disulfiram Interactions With HIV Medications: Clinical Implications
• Date of first enrolment: November 2008
• Target sample size: 40
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00878306
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Countries of recruitment

United States

Contacts

• Name: Elinore F McCance-Katz, M.D., Ph.D
• Affiliation: University of California, San Francisco

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Drug Abuse

HIV Infections

Intervention(s)

Drug: Disulfiram

Drug: Disulfiram + Atazanavir

Drug: Disulfiram + Efavirenz

Drug: Disulfiram + Ritonavir

Primary Outcome(s)

The effect of disulfiram on the pharmacokinetics of each of the antiretroviral medications to be studied [Time Frame: Measured at Day 15]

Secondary Outcome(s)

Cardiac Conduction [Time Frame: Measured at screening and during pharmacokinetic studies]

Hepatic Function [Time Frame: Measured at screening and during pharmacokinetic studies]

Safety of co-administration of alcohol containing HIV preparations (ritonavir) and Disulfiram [Time Frame: Measured at day 11- day 15]

Serum Lipids [Time Frame: Measured at screening and during pharmacokinetic studies]

The effect of the antiretroviral medications on disulfiram measured by ALDH activity and disulfiram pharmacokinetics [Time Frame: Measured at Day 0, Day 4, and Day 8]

Secondary ID(s)

R01DA 024982

R01DA024982

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute on Drug Abuse (NIDA)