search
Back to results

Pharmacotherapy 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Withdrawn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
VA Connecticut Healthcare System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infection focused on measuring HIV, alcohol, naltrexone, Treatment Experienced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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

    First Posted
    March 2, 2009
    Last Updated
    March 27, 2012
    Sponsor
    VA Connecticut Healthcare System
    Collaborators
    Yale University
    search

    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

    We'll reach out to this number within 24 hrs