Pharmacotherapy for HIV Infected Patients With Alcohol Problems

Study Overview
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Brief Summary
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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.

Official Title
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Pharmacotherapy for HIV Infected Patients With Alcohol Problems

Conditions
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HIV Infection, Heavy Alcoholic Consumption, HIV Infections

Intervention / Treatment
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* Drug: Naltrexone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be HIV-positive. 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. Not be abstinent from alcohol for greater than 30 days. Be at least 18 years old. Be able to understand English and provide informed consent Exclusion Criteria: Be psychotic or severely psychiatrically disabled. Have medical conditions that would preclude completing or be of harm during the course of the study. 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. Have a known contraindication to naltrexone therapy (e.g. taking opioid medication for pain). Be pregnant, nursing or unable to use an effective method of birth control (women). Subjects who are taking or use narcotics will not be included because naltrexone will precipitate withdrawal.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Naltrexone | Drug: Naltrexone<br>* Naltrexone dose 25-100mg<br>* Other names: Revia;|
| Placebo Comparator: 2<br> | Drug: Naltrexone<br>* Naltrexone dose 25-100mg<br>* Other names: Revia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of heavy drinking |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV biological markers |  | 12 weeks | 
| Sexual risk behavior |  | 12 weeks | 
| Tolerability and retention in alcohol treatment |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, alcohol, naltrexone, Treatment Experienced