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Trial record 43 of 126 for:    "Viral Infectious Disease" | "Ethanol"

Pharmacotherapy for HIV Infected Patients With Alcohol Problems

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00854230
Recruitment Status : Withdrawn (We expanded to a bigger, multi-site study & decided to close this study.)
First Posted : March 3, 2009
Last Update Posted : March 28, 2012
Yale University
Information provided by (Responsible Party):
VA Connecticut Healthcare System

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.

Condition or disease Intervention/treatment Phase
HIV Infection Heavy Alcoholic Consumption HIV Infections Drug: Naltrexone Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pharmacotherapy for HIV Infected Patients With Alcohol Problems
Study Start Date : January 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: 1
Drug: Naltrexone
Naltrexone dose 25-100mg
Other Name: Revia

Placebo Comparator: 2 Drug: Naltrexone
Naltrexone dose 25-100mg
Other Name: Revia

Primary Outcome Measures :
  1. Frequency of heavy drinking [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. HIV biological markers [ Time Frame: 12 weeks ]
  2. Sexual risk behavior [ Time Frame: 12 weeks ]
  3. Tolerability and retention in alcohol treatment [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00854230

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

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Responsible Party: VA Connecticut Healthcare System Identifier: NCT00854230     History of Changes
Other Study ID Numbers: AJ0007
First Posted: March 3, 2009    Key Record Dates
Last Update Posted: March 28, 2012
Last Verified: March 2012
Keywords provided by VA Connecticut Healthcare System:
Treatment Experienced
Additional relevant MeSH terms:
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RNA Virus Infections
Virus Diseases
Slow Virus Diseases
Alcohol Deterrents
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Narcotic Antagonists
Sensory System Agents
Peripheral Nervous System Agents