Disulfiram Interactions With HIV Medications: Clinical Implications

NCT00878306 | Completed Phase 1

• 1 other identifier: R01DA024982
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; Drug Abuse

Keywords

Treatment of drug dependency with HIV medications; HIV

Outcome Measures

Primary Outcomes (1)

• The effect of disulfiram on the pharmacokinetics of each of the antiretroviral medications to be studied

  Measured at Day 15

Secondary Outcomes (5)

• The effect of the antiretroviral medications on disulfiram measured by ALDH activity and disulfiram pharmacokinetics

  Measured at Day 0, Day 4, and Day 8

• Cardiac Conduction

  Measured at screening and during pharmacokinetic studies

• Hepatic Function

  Measured at screening and during pharmacokinetic studies

• Serum Lipids

  Measured at screening and during pharmacokinetic studies

• Safety of co-administration of alcohol containing HIV preparations (ritonavir) and Disulfiram

  Measured at day 11- day 15

Study Arms (4)

Disulfiram

ACTIVE COMPARATOR

Disulfiram

Drug: Disulfiram

Disulfiram + Efavirenz

EXPERIMENTAL

Efavirenz alone, then in addition with Disulfiram

Drug: Disulfiram + Efavirenz

Disulfiram + Atazanavir

EXPERIMENTAL

Atazanavir alone, then in addition with Disulfiram

Drug: Disulfiram + Atazanavir

Disulfiram + Ritonavir

EXPERIMENTAL

Ritonavir alone, then in addition with Disulfiram

Drug: Disulfiram + Ritonavir

Interventions

Disulfiram DRUG

62.5 mg daily x3 days, then 250 mg daily x3 days

Also known as: Antabuse

Disulfiram

Disulfiram + Efavirenz DRUG

Efavirenz 600 mg daily x10 days, then in addition with 62.5 mg daily x3 days, then Disulfiram 250 mg daily x3 days

Disulfiram + Efavirenz

Disulfiram + Atazanavir DRUG

Atazanavir 400 mg daily x8 days, then in addition with 62.5 mg daily x3 days, then Disulfiram 250 mg daily x3 days

Disulfiram + Atazanavir

Disulfiram + Ritonavir DRUG

Ritonavir 200 mg daily x8 days, then in addition with 62.5 mg daily x3 days, then Disulfiram 250 mg daily x3 days

Disulfiram + Ritonavir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age or older
• Willing to abstain from alcohol during the study and for two weeks afterward

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

San Francisco General Hospital

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

HIV Infections; Substance-Related Disorders

Interventions

Disulfiram; efavirenz; Atazanavir Sulfate; Ritonavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Ditiocarb; Thiocarbamates; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Disulfides; Sulfides; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Thiazoles; Azoles

Study Officials

• Elinore F McCance-Katz, M.D., Ph.D

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2009
• First Posted: April 8, 2009
• Study Start: November 1, 2008
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: May 6, 2014

Record last verified: 2014-05

Locations

US (1)