Pharmacotherapy for HIV Infected Patients With Alcohol Problems

Phase 4

Withdrawn

• Conditions: HIV Infection; Heavy Alcoholic Consumption; HIV Infections
• Interventions: Drug: Naltrexone

• Registration Number: NCT00854230
• Lead Sponsor: VA Connecticut Healthcare System

Brief Summary

This is a randomized double blind clinical trial to test the effect of Naltrexone on HIV infected heavy drinkers. The study will select 40 HIV positive patients who meet criteria for heavy drinking. Treatments include Naltrexone (25-100mg)and placebo. Patients will be treated, followed up, and assessed for a duration of 12 weeks.

The investigators associated hypotheses Hypothesis 1: Naltrexone will reduce the frequency of heavy drinking. Hypothesis 2: Naltrexone will lead to maintenance or improvement in CD4 lymphocyte count and decreased HIV RNA levels.

Hypothesis 3: Naltrexone will lead to a reduction in sexual risk behaviors. Hypothesis 4: Naltrexone will lead to improved adherence to HAART. Hypothesis 5 (Exploratory): Naltrexone will be well-tolerated with minimal side effects and patients will exhibit good treatment retention.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-03-02
• Study First Submitted QC: 2009-03-02
• Study First Posted: 2009-03-03
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-27
• Last Update Posted: 2012-03-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Be HIV-positive.
2. Report heavy drinking 4 or more times in the past 4 weeks. Heavy drinking is defined as 4 or more drinks for women and 5 or more drinks for men on any occasion.
3. Not be abstinent from alcohol for greater than 30 days.
4. Be at least 18 years old.
5. Be able to understand English and provide informed consent

Exclusion Criteria

1. Be psychotic or severely psychiatrically disabled.
2. Have medical conditions that would preclude completing or be of harm during the course of the study.
3. Have laboratory or clinical evidence of significant liver dysfunction (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limit of the normal range) or cirrhosis.
4. Have a known contraindication to naltrexone therapy (e.g. taking opioid medication for pain).
5. Be pregnant, nursing or unable to use an effective method of birth control (women).
6. Subjects who are taking or use narcotics will not be included because naltrexone will precipitate withdrawal.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Naltrexone	-
1	Naltrexone	Naltrexone

Primary Outcome Measures

Name	Time	Method
Frequency of heavy drinking	12 weeks

Secondary Outcome Measures

Name	Time	Method
HIV biological markers	12 weeks
Sexual risk behavior	12 weeks
Tolerability and retention in alcohol treatment	12 weeks