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This study has been withdrawn prior to enrollment.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
  Purpose

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.


Condition Intervention Phase
HIV Infection
Heavy Alcoholic Consumption
HIV Infections
Drug: Naltrexone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pharmacotherapy for HIV Infected Patients With Alcohol Problems

Resource links provided by NLM:


Further study details as provided by VA Connecticut Healthcare System:

Primary Outcome Measures:
  • Frequency of heavy drinking [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: January 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Naltrexone
Drug: Naltrexone
Naltrexone dose 25-100mg
Other Name: Revia
Placebo Comparator: 2 Drug: Naltrexone
Naltrexone dose 25-100mg
Other Name: Revia

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00854230

Sponsors and Collaborators
VA Connecticut Healthcare System
Yale University
Investigators
Principal Investigator: David A Fiellin, Md Yale University
Principal Investigator: Amy Justice, MD, PhD Yale University, West Haven VA hospital
  More Information

No publications provided

Responsible Party: VA Connecticut Healthcare System
ClinicalTrials.gov Identifier: NCT00854230     History of Changes
Other Study ID Numbers: AJ0007, 0901004647
Study First Received: March 2, 2009
Last Updated: March 27, 2012
Health Authority: United States: Federal Government

Keywords provided by VA Connecticut Healthcare System:
HIV
alcohol
naltrexone
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Infection
Communicable Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014