Pharmacotherapy for HIV Infected Patients With Alcohol Problems

March 27, 2012 updated by: VA Connecticut Healthcare System

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Drug: Naltrexone
Naltrexone dose 25-100mg
Other Names:
  • Revia
Experimental: 1
Naltrexone
Drug: Naltrexone
Naltrexone dose 25-100mg
Other Names:
  • Revia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of heavy drinking
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Connecticut Healthcare System

Collaborators

Yale University

Investigators

  • Principal Investigator: David A Fiellin, Md, Yale University
  • Principal Investigator: Amy Justice, MD, PhD, Yale University, West Haven VA hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

March 2, 2009

First Submitted That Met QC Criteria

March 2, 2009

First Posted (Estimate)

March 3, 2009

Study Record Updates

Last Update Posted (Estimate)

March 28, 2012

Last Update Submitted That Met QC Criteria

March 27, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AJ0007
  • 0901004647

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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