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
Autor: | Breanne E. Biondi, Maureen Desabrais, Marwan M. Azar, Daniel J. Skiest, Frederick L. Altice, Russell Barbour, Angela Di Paola, Thomas M. Lincoln, Sandra A. Springer |
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Rok vydání: | 2018 |
Předmět: |
Male
Research design Time Factors Narcotic Antagonists HIV Infections Naltrexone law.invention 0302 clinical medicine Randomized controlled trial law Criminal Law Pharmacology (medical) Prospective Studies 030212 general & internal medicine Prospective cohort study Opioid-Related Disorders Opioid use disorder Middle Aged Viral Load Treatment Outcome Infectious Diseases Research Design RNA Viral Female 0305 other medical science Viral load medicine.drug Adult medicine.medical_specialty Placebo Injections Intramuscular Article 03 medical and health sciences Double-Blind Method Internal medicine medicine Humans 030505 public health business.industry Prisoners social sciences medicine.disease Delayed-Action Preparations Multivariate Analysis HIV-1 business human activities Follow-Up Studies |
Zdroj: | JAIDS Journal of Acquired Immune Deficiency Syndromes. 78:43-53 |
ISSN: | 1525-4135 |
Popis: | 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.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.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.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.XR-NTX improves or maintains VS after release to the community for incarcerated people living with HIV with OUD. |
Databáze: | OpenAIRE |
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