Status:
COMPLETED
Interaction of Alcohol and Highly Active Antiretroviral Therapy (HAART) in HIV/AIDS and HIV/AIDS With Hepatitis C Virus (HCV) Co-Infection
Lead Sponsor:
University of California, San Francisco
Conditions:
HIV Infections
Hepatitis C
Eligibility:
All Genders
21+ years
Phase:
PHASE1
Brief 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...
Detailed Description
The goal of this research study is to improve the clinical care of human immunodeficiency virus (HIV)-infected or HIV/Hepatitis C (HCV) co-infected, alcohol-using patients by identifying significant i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00879047
Start Date
April 1 2009
End Date
April 1 2013
Last Update
May 6 2014
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94115