Interaction of Alcohol and Highly Active Antiretroviral Therapy (HAART) in HIV/AIDS and HIV/AIDS With Hepatitis C Virus (HCV) Co-Infection
Completed · Phase 1 · Has a placebo group
Conditions studied: HIV Infections, Hepatitis C
In brief
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.
Key facts
- Study ID
- NCT00879047
- Run by
- University of California, San Francisco
- People needed
- 30
- Starts
- 2009-04-01
- Expected to finish
- 2013-04-01
- Last updated by the study team
- 2014-05-06
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
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 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.
Where it is running
- University of California, San Francisco — San Francisco, California, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.