MedTrace Logo

Naltrexone for Medication Compliance Among HIV-infected Men With Alcohol Use Disorder

NCT01377168 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2017-06-16

No results posted yet for this study

Summary

This study will recruit 159 HIV-infected men with alcohol use disorders (AUDs). Men will be randomized to receive either oral naltrexone for the treatment of alcohol use disorder or placebo. Men with acute, recent or established HIV infection will receive antiretroviral treatment (ART) and be randomized to oral naltrexone or placebo. The purpose of this study is to see whether use of oral naltrexone improves medication compliance, and therefore HIV viral load suppression, among men with alcohol use disorder. The study will also assess the impact of oral naltrexone on alcohol use behaviors in this population.

Conditions

Interventions

DRUG

oral naltrexone

DRUG

Placebo pill

Sponsors & Collaborators

  • Yale University

    collaborator OTHER

  • Asociación Civil Impacta Salud y Educación, Peru

    collaborator OTHER

  • Fred Hutchinson Cancer Center

    lead OTHER

Principal Investigators

  • Ann Duerr, MD, PhD, MPH · Fred Hutchinson Cancer Center

  • Frederick Altice, MD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2016-06-30
Completion
2017-06-30

Countries

  • Peru

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01377168 on ClinicalTrials.gov