N/A
Completed N=100
Alcohol Pharmacotherapy for HIV+ Prisoners
alcohol dependence · Problem Drinking · Hazardous Drinking · Human Immunodeficiency Virus Infection
Source: ClinicalTrials.gov NCT01077310 ↗
Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Nov 2016
Primary outcomePrimary: Percentage of Those Maintain or Improve to HIV RNA-1 Viral Load Less Then 400 Copies/mL — 54; 42 percent of participants
Summary
This is a randomized controlled trial of injectable intramuscular naltrexone (XR-NTX) versus intramuscular placebo among HIV-infected prisoners meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for alcohol dependence or problem drinking, who are transitioning to the community and seeking treatment to prevent relapse to alcohol use. We hypothesize that extended release naltrexone (XR-NTX) will result in improved HIV outcomes (lower log10 HIV-1RNA levels and higher CD4 count) as well as improved alcohol treatment outcomes, and reduced drug/sex HIV related risk behaviors and decreased rates of reincarceration.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Those Maintain or Improve to HIV RNA-1 Viral Load Less Then 400 Copies/mL |
54; 42 | — |
| SECONDARY Alcohol Treatment Outcome: Time to Alcohol Relapse |
24.1; 9.5; 78.9; 73.9; 98.8; 85.0 | — |
| SECONDARY Alcohol Treatment Outcome: Change in Average Drinks Per Drinking Day |
-16.6; -29.6; -17.4; -14.9 | — |
| SECONDARY Alcohol Treatment Outcome: Change in Percent of Heavy Drinking Days |
-38.3; -51.3; -63.6; -54.9 | — |
Eligibility Criteria
Inclusion Criteria
- HIV+
- Inmates returning to New Haven or Hartford
- Meets criteria for alcohol dependence (using Diagnostic and Statistical Manual IV) or problem drinking (using Alcohol Use Disorder Identification Test-AUDIT)
- Gives informed consent
- English or Spanish speaker
- > 18 yrs
Exclusion Criteria
- On opiate pain medication or expressing need for them
- Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) > 5x the upper limit of normal
- Evidence of Child's Pugh Class C cirrhosis
- Pending felony charges
- Pregnant or unwilling to take contraceptive measures
- Subject is part of another pharmacological research study
Data sourced from ClinicalTrials.gov (NCT01077310). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.