Pharmacotherapy for HIV Infected Patients With Alcohol Problems
Trial Snapshot
- Phase
- Phase 4
- Status
- Withdrawn
- Sponsor
- Primary Endpoint
- Frequency of heavy drinking
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
1
Naltrexone
Intervention: Naltrexone (Drug)
2
Intervention: Naltrexone (Drug)
Outcomes
Primary Outcomes
Frequency of heavy drinking
Time Frame: 12 weeks
Secondary Outcomes
- HIV biological markers(12 weeks)
- Sexual risk behavior(12 weeks)
- Tolerability and retention in alcohol treatment(12 weeks)