Pharmacotherapy for HIV Infected Patients With Alcohol Problems

NCT00854230 | Withdrawn Phase 4 DMC

• 2 other identifiers: AJ00070901004647
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HIV Infection; Heavy Alcoholic Consumption; HIV Infections

Keywords

HIV; alcohol; naltrexone; Treatment Experienced

Outcome Measures

Primary Outcomes (1)

• Frequency of heavy drinking

  12 weeks

Secondary Outcomes (3)

• HIV biological markers

  12 weeks

• Sexual risk behavior

  12 weeks

• Tolerability and retention in alcohol treatment

  12 weeks

Study Arms (2)

1

EXPERIMENTAL

Naltrexone

Drug: Naltrexone

2

PLACEBO COMPARATOR

Drug: Naltrexone

Interventions

Naltrexone DRUG

Naltrexone dose 25-100mg

Also known as: Revia

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Connecticut Healthcare System: lead
• Yale University: collaborator

MeSH Terms

Conditions

HIV Infections

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• David A Fiellin, Md

  Yale University

  PRINCIPAL INVESTIGATOR

• Amy Justice, MD, PhD

  Yale University, West Haven VA hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2009
• First Posted: March 3, 2009
• Study Start: January 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: March 28, 2012

Record last verified: 2012-03