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Randomized Controlled Trial
. 2018 May 1;78(1):43-53.
doi: 10.1097/QAI.0000000000001634.

Extended-Release Naltrexone Improves Viral Suppression Among Incarcerated Persons Living With HIV With Opioid Use Disorders Transitioning to the Community: Results of a Double-Blind, Placebo-Controlled Randomized Trial

Sandra A Springer  1   2 , Angela Di Paola  3 , Marwan M Azar  1 , Russell Barbour  2 , Breanne E Biondi  1 , Maureen Desabrais  4 , Thomas Lincoln  4 , Daniel J Skiest  4 , Frederick L Altice  1   2   5   6
Affiliations
Randomized Controlled Trial

Extended-Release Naltrexone Improves Viral Suppression Among Incarcerated Persons Living With HIV With Opioid Use Disorders Transitioning to the Community: Results of a Double-Blind, Placebo-Controlled Randomized Trial

Sandra A Springer et al. J Acquir Immune Defic Syndr. .

Abstract

Objective: To determine whether extended-release naltrexone (XR-NTX) would improve or maintain viral suppression (VS) among prisoners or jail detainees with HIV and opioid use disorder (OUD) transitioning to the community.

Design: A 4-site, prospective randomized double-blind, placebo-controlled trial was conducted among prison and jail inmates with HIV and OUD transitioning to the community from September 2010 through March 2016.

Methods: Eligible participants (N = 93) were randomized 2:1 to receive 6 monthly injections of XR-NTX (n = 66) or placebo (n = 27) starting at release and observed for 6 months. The primary outcome was the proportion that maintained or improved VS (<50 copies/mL) from baseline to 6 months.

Results: Participants allocated to XR-NTX significantly improved to VS (<50 copies/mL) from baseline (37.9%) to 6 months (60.6%) (P = 0.002), whereas the placebo group did not (55.6% at baseline to 40.7% at 6 months P = 0.294). There was, however, no statistical significant difference in VS levels at 6 months between XR-NTX (60.6%) vs. placebo (40.7%) (P = 0.087). After controlling for other factors, only allocation to XR-NTX (adjusted odds ratio = 2.90; 95% confidence interval = 1.04 to 8.14, P = 0.043) was associated with the primary outcome. Trajectories in VS from baseline to 6 months differed significantly (P = 0.017) between treatment groups, and the differences in the discordant values were significantly different as well (P = 0.041): the XR-NTX group was more likely than the placebo group to improve VS (30.3% vs. 18.5%), maintain VS (30.3% vs. 27.3), and less likely to lose VS (7.6% vs. 33.3%) by 6 months.

Conclusions: XR-NTX improves or maintains VS after release to the community for incarcerated people living with HIV with OUD.

Trial registration: ClinicalTrials.gov NCT01246401.

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Figures

Figure 1
Figure 1
Study Enrollment Flow Chart.
Figure 2
Figure 2
Change in Viral Suppression (<50 copies/mL) from Baseline to 6 months
Figure 3
Figure 3
Distribution of Viral Suppression (<50 copies/mL) Category by Treatment Group From Baseline to 6 Months Pearson chi squared was evaluating difference in distribution of observations for the 4 categories between groups and was statistically significant (p=0.017). Discordant observation over time within groups and Between groups was evaluated with McNemar’s chi-square test, and was statistically significant (p=0.041)
Figure 4
Figure 4
Kaplan Meier Curve Days of Continuous Opioid Abstinence 4a. Intention to treat analysis; 4b. As-treated Analysis by Treatment Grouping.
Figure 5
Figure 5. Six month Study retention
XR-NTX=extended-release naltrexone
See this image and copyright information in PMC

References

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