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

NCT00879047 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2014-05-06

No results posted yet for this study

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.

Conditions

  • HIV Infections
  • Hepatitis C

Interventions

DRUG

Alcohol

Consumed orally as liquid mixed with a juice beverage, 1 g/kg formula, administered once at baseline and again at either 2 or 3 weeks

DRUG

Alcohol placebo

Liquid alcohol spritzed on top of juice beverage immediately prior to administration in order to give smell of alcohol, administered once at baseline and again at either 2 or 3 weeks

Sponsors & Collaborators

Principal Investigators

  • Elinore F McCance-Katz, M.D., Ph.D. · University of California, San Francisco

Study Design

Allocation
NON_RANDOMIZED
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00879047 on ClinicalTrials.gov