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AIDS Behav. 2018 Aug 2. doi: 10.1007/s10461-018-2241-z. [Epub ahead of print]

Efficacy of Extended-Release Naltrexone on HIV-Related and Drinking Outcomes Among HIV-Positive Patients: A Randomized-Controlled Trial.

Author information

1
Yale School of Medicine, Yale University, New Haven, CT, USA. ejennifer.edelman@yale.edu.
2
Center for Interdisciplinary Research on AIDS, Yale School of Public Health, New Haven, CT, USA. ejennifer.edelman@yale.edu.
3
Yale University School of Medicine and Public Health, 367 Cedar Street, E.S. Harkness Memorial Hall, Building A, Suite 401, New Haven, CT, 06510, USA. ejennifer.edelman@yale.edu.
4
Yale School of Medicine, Yale University, New Haven, CT, USA.
5
VA Connecticut Healthcare System, West Haven, CT, USA.
6
Center for Interdisciplinary Research on AIDS, Yale School of Public Health, New Haven, CT, USA.
7
College of Public Health, University of Georgia, Athens, GA, USA.
8
Yale Center for Analytic Sciences, Yale University School of Public Health, Yale University, New Haven, CT, USA.
9
James J. Peters VA Medical Center, Bronx, NY, USA.
10
National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA.
11
Yale Child Study Center, Yale University, New Haven, CT, USA.

Abstract

We sought to test the efficacy of extended-release naltrexone (XR-NTX) on HIV-related and drinking outcomes. From April 2011-February 2015, we conducted a 4-site randomized double-blind placebo controlled clinical trial involving 51 HIV-positive patients with heavy drinking and < 95% antiretroviral (ART) adherence. All participants received counseling. The primary outcome was proportion with ≥ 95% ART adherence. Secondary outcomes included HIV biomarkers, VACS Index score, and past 30-day heavy drinking days. Based on receipt of ≥ 5 injections, 23 participants were retained at 24 weeks. We did not detect an effect of XR-NTX on ART adherence (p = 0.38); undetectable HIV viral load (p = 0.26); CD4 cell count (p = 0.75) or VACS Index score (p = 0.70). XR-NTX was associated with fewer heavy drinking days (p = 0.03). While XR-NTX decreases heavy drinking days, we did not detect improvements in ART adherence or HIV outcomes. Strategies to improve retention in alcohol treatment and HIV-related outcomes among heavy drinking HIV-positive patients are needed.

KEYWORDS:

Alcohol; Extended-release naltrexone; HIV; Randomized clinical trial

PMID:
30073637
DOI:
10.1007/s10461-018-2241-z

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