Back to resultsPharmacotherapy for HIV Infected Patients With Alcohol Problems
Primary Purpose
HIV Infection, Heavy Alcoholic Consumption, HIV Infections
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Naltrexone
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infection focused on measuring HIV, alcohol, naltrexone, Treatment Experienced
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Naltrexone
Outcomes
Primary Outcome Measures
Frequency of heavy drinking
Secondary Outcome Measures
HIV biological markers
Sexual risk behavior
Tolerability and retention in alcohol treatment
Full Information
NCT ID
NCT00854230
First Posted
March 2, 2009
Last Updated
March 27, 2012
Sponsor
VA Connecticut Healthcare System
Collaborators
Yale University
1. Study Identification
Unique Protocol Identification Number
NCT00854230
Brief Title
Pharmacotherapy for HIV Infected Patients With Alcohol Problems
Official Title
Pharmacotherapy for HIV Infected Patients With Alcohol Problems
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Withdrawn
Why Stopped
We expanded to a bigger, multi-site study & decided to close this study.
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Connecticut Healthcare System
Collaborators
Yale University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection, Heavy Alcoholic Consumption, HIV Infections
Keywords
HIV, alcohol, naltrexone, Treatment Experienced
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Naltrexone
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Naltrexone
Other Intervention Name(s)
Revia
Intervention Description
Naltrexone dose 25-100mg
Primary Outcome Measure Information:
Title
Frequency of heavy drinking
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
HIV biological markers
Time Frame
12 weeks
Title
Sexual risk behavior
Time Frame
12 weeks
Title
Tolerability and retention in alcohol treatment
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A Fiellin, Md
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amy Justice, MD, PhD
Organizational Affiliation
Yale University, West Haven VA hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Pharmacotherapy for HIV Infected Patients With Alcohol Problems
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