HIV Infections Clinical Trial
Official title:
Interaction of Alcohol & HAART in HIV/AIDS and HIV/AIDS With HCV Co-Infection
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | April 2013 |
Est. primary completion date | April 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 21 Years and older |
Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Plasma levels of antiretroviral medications. | Baseline, two weeks, and three weeks. | No | |
Primary | Plasma levels of alcohol. | Baseline, two weeks, and three weeks. | No | |
Secondary | Measures of cognitive and behavioral change/impairment. | Baseline, two weeks, and three weeks. | No |
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