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

E Jennifer Edelman, Brent A Moore, Stephen R Holt, Nathan Hansen, Tassos C Kyriakides, Michael Virata, Sheldon T Brown, Amy C Justice, Kendall J Bryant, David A Fiellin, Lynn E Fiellin, E Jennifer Edelman, Brent A Moore, Stephen R Holt, Nathan Hansen, Tassos C Kyriakides, Michael Virata, Sheldon T Brown, Amy C Justice, Kendall J Bryant, David A Fiellin, Lynn E Fiellin

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.

Conflict of interest statement

Conflicts of Interest: The authors have no conflicts of interest.

Conflict of Interest: The authors have no conflicts of interest to disclose.

Figures

Figure I.
Figure I.
CONSORT Flow Diagram
Figure II.
Figure II.
Estimated proportion achieving ≥95% ART Adherence Note: p value for group=0.38, group*time=0.97. NTX=extended release naltrexone; PCB=placebo. Presented values are adjusted for baseline differences.
Figure III.
Figure III.
HIV biomarkers: Proportion achieving an undetectable HIV viral load and mean CD4 cell count Notes: Proportion achieving an undetectable viral load: p value for group=0.26, group*time=0.20; Estimated mean CD4 cell count: p value for group=0.75, group*time=0.01. NTX=extended release naltrexone; PCB=placebo. Presented values are adjusted for baseline differences and using imputed values.
Figure IV.
Figure IV.
Estimated number of heavy drinking days, past 30 days Notes: p value for group=0.03, group*time=0.63; NTX=extended release naltrexone; PCB=placebo. Presented values are adjusted for baseline differences.

Source: PubMed

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