Pharmacotherapy for HIV Infected Patients With Alcohol Problems

HIV Infections Clinical Trial

Official title:

Pharmacotherapy for HIV Infected Patients With Alcohol Problems

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00854230
• Other study ID #: AJ0007
• Secondary ID: 0901004647
• Status: Withdrawn
• Phase: Phase 4
• First received: March 2, 2009
• Last updated: March 27, 2012
• Start date: January 2009
• Est. completion date: January 2010

Study information

• Verified date: March 2012
• Source: VA Connecticut Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Heavy Alcoholic Consumption
• HIV Infection
• HIV Infections
• Infection

Intervention

Drug:
• Naltrexone
Naltrexone dose 25-100mg

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
VA Connecticut Healthcare System	Yale University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of heavy drinking		12 weeks	No
Secondary	HIV biological markers		12 weeks	No
Secondary	Sexual risk behavior		12 weeks	No
Secondary	Tolerability and retention in alcohol treatment		12 weeks	Yes