Pharmacotherapy for HIV Infected Patients With Alcohol Problems

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-01-31

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.

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Detailed Description

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Conditions

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HIV Infection Heavy Alcoholic Consumption HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Naltrexone

Group Type EXPERIMENTAL

Naltrexone

Intervention Type DRUG

Naltrexone dose 25-100mg

2

Group Type PLACEBO_COMPARATOR

Naltrexone

Intervention Type DRUG

Naltrexone dose 25-100mg

Interventions

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Naltrexone

Naltrexone dose 25-100mg

Intervention Type DRUG

Other Intervention Names

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Revia

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No