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

NCT00879047 | Completed Phase 1 DMC

• 1 other identifier: R01AA018001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 HCV and healthy subjects.

Conditions

HIV Infections; Hepatitis C

Keywords

HIV; Hepatitis C

Outcome Measures

Primary Outcomes (2)

• Plasma levels of antiretroviral medications.

  Baseline, two weeks, and three weeks.

• Plasma levels of alcohol.

  Baseline, two weeks, and three weeks.

Secondary Outcomes (1)

• Measures of cognitive and behavioral change/impairment.

  Baseline, two weeks, and three weeks.

Study Arms (5)

HIV+, Ritonavir-regimen

EXPERIMENTAL

10 subjects will be HIV+ and will begin receiving Ritonavir-containing regimen, and their PK interactions with alcohol/placebo will be evaluated.

Drug: Alcohol; Drug: Alcohol placebo

HIV+/HCV+ Co-infected, Ritonavir-regimen

EXPERIMENTAL

10 subjects will be HIV+/HCV+ co-infected and will begin receiving Ritonavir-containing regimen, and their PK interactions with alcohol/placebo will be evaluated.

Drug: Alcohol; Drug: Alcohol placebo

HIV+, Efavirenz-regimen

EXPERIMENTAL

10 subjects will be HIV+ and will begin receiving Efavirenz-containing regimen, and their PK interactions with alcohol/placebo will be evaluated.

Drug: Alcohol; Drug: Alcohol placebo

HIV+/HCV+ Co-infected, Efavirenz-regimen

EXPERIMENTAL

10 subjects will be HIV+/HCV+ co-infected and will begin receiving Efavirenz-containing regimen, and their PK interactions with alcohol/placebo will be evaluated.

Drug: Alcohol; Drug: Alcohol placebo

Maraviroc in Healthy Subjects

EXPERIMENTAL

10 healthy subjects will begin receiving maraviroc, and their PK interactions with alcohol/placebo will be evaluated.

Drug: Alcohol; Drug: Alcohol placebo

Interventions

Alcohol DRUG

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

Also known as: grain alcohol

HIV+, Efavirenz-regimen; HIV+, Ritonavir-regimen; HIV+/HCV+ Co-infected, Efavirenz-regimen; HIV+/HCV+ Co-infected, Ritonavir-regimen; Maraviroc in Healthy Subjects

Alcohol placebo DRUG

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

Also known as: grain alcohol

HIV+, Efavirenz-regimen; HIV+, Ritonavir-regimen; HIV+/HCV+ Co-infected, Efavirenz-regimen; HIV+/HCV+ Co-infected, Ritonavir-regimen; Maraviroc in Healthy Subjects

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

HIV Infections; Hepatitis C

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hepatitis, Viral, Human; Flaviviridae Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Elinore F McCance-Katz, M.D., Ph.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2009
• First Posted: April 9, 2009
• Study Start: April 1, 2009
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: May 6, 2014

Record last verified: 2014-05

Locations

US (1)