Interaction of Alcohol and Highly Active Antiretroviral Therapy (HAART) in HIV/AIDS and HIV/AIDS With Hepatitis C Virus (HCV) Co-Infection

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

Summary

The proposed studies will examine the extent of pharmacokinetic and pharmacodynamic interactions between alcohol and various antiretroviral therapies in those with HIV/AIDS, HIV/HCV co-infection, mild HCV and healthy subjects.

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

Details

• Lead Sponsor: University of California, San Francisco
• Treatments: Efavirenz; Ethanol; Ritonavir

Criteria

Inclusion Criteria:

• Participants will be diagnosed with HIV/AIDS, HIV/AIDS and Hepatitis C, mild Hepatitis C or will be healthy as determined by history and physical examination, screening laboratory tests and urinalysis, and will be eligible for treatment with HAART

• Participants will be experienced with alcohol consumption

• They may meet diagnostic criteria for alcohol abuse or non-physiological alcohol dependence, but may not be dependent on any other substances including opioids, stimulants, cannabis, hallucinogens or other substances, prescribed or illicit

• For those with HCV coinfection, HCV must be at a stage consistent with no more than mild liver fibrosis (fibrosis stage assessed by two methods: the AST to platelet ratio (APRI) (at a score of <0.5 for eligibility) and the FIB-4 fibrosis index (score of <1.5 for eligibility), both of which indicate mild liver disease.)

• Age 21 or older

• Hemoglobin Men > 11 g/dL, Women > 10 g/dL5

• Able to give voluntary, signed, informed consent.

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 women or nursing mothers.

• All women who are sexually active and capable of becoming pregnant must have a negative pregnancy test within one week prior to entry into these studies.

• Major psychotic illness or suicidality.

• Clinically active hepatitis with liver enzyme elevations > 3 times the upper limit of normal or evidence of liver fibrosis at a stage indicative of greater than mild stage for fibrosis (see Inclusion Criteria).

• Those with obesity (BMI > 30), diabetes, hyperlipidemia, coagulation disorders, or renal disease will be excluded.

• Hemoglobin Men < 11 g/dL, Women < 10 g/dL

• Physical dependence on alcohol.