Pharmacotherapy for HIV Infected Patients With Alcohol Problems

This study has been withdrawn prior to enrollment.
(We expanded to a bigger, multi-site study & decided to close this study.)
Sponsor:
Collaborator:
Yale University
Information provided by (Responsible Party):
VA Connecticut Healthcare System
ClinicalTrials.gov Identifier:
NCT00854230
First received: March 2, 2009
Last updated: March 27, 2012
Last verified: March 2012

March 2, 2009
March 27, 2012
January 2009
January 2010   (final data collection date for primary outcome measure)
Frequency of heavy drinking [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00854230 on ClinicalTrials.gov Archive Site
  • HIV biological markers [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Sexual risk behavior [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Tolerability and retention in alcohol treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Pharmacotherapy for HIV Infected Patients With Alcohol Problems
Pharmacotherapy for HIV Infected Patients With Alcohol Problems

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • HIV Infection
  • Heavy Alcoholic Consumption
  • HIV Infections
Drug: Naltrexone
Naltrexone dose 25-100mg
Other Name: Revia
  • Experimental: 1
    Naltrexone
    Intervention: Drug: Naltrexone
  • Placebo Comparator: 2
    Intervention: Drug: Naltrexone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
January 2010
January 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00854230
AJ0007, 0901004647
Yes
VA Connecticut Healthcare System
VA Connecticut Healthcare System
Yale University
Principal Investigator: David A Fiellin, Md Yale University
Principal Investigator: Amy Justice, MD, PhD Yale University, West Haven VA hospital
VA Connecticut Healthcare System
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP