Slow-release naltrexone implant versus oral naltrexone for improving treatment outcomes in people with HIV who are addicted to opioids: a double-blind, placebo-controlled, randomised trial

Publication date: Available online 14 March 2019Source: The Lancet HIVAuthor(s): Evgeny Krupitsky, Elena Blokhina, Edwin Zvartau, Elena Verbitskaya, Dmitri Lioznov, Tatiana Yaroslavtseva, Vladimir Palatkin, Marina Vetrova, Natalia Bushara, Andrei Burakov, Dmitri Masalov, Olga Mamontova, Daniel Langleben, Sabrina Poole, Robert Gross, George WoodySummaryBackgroundUntreated opioid addiction in people with HIV is associated with poor HIV treatment outcomes. Slow-release, long-acting, implantable naltrexone might improve these outcomes. Here, we present results of a study aimed to test this hypothesis.MethodsWe did a 48 week double-blind, double-dummy, placebo-controlled, phase 3, randomised trial with men and women addicted to opioids who were starting antiretroviral therapy (ART) for HIV and whose viral loads were higher than 1000 copies per mL. Participants were seeking treatment at two HIV and two narcology programme centres in Saint Petersburg, Russia, and the surrounding Leningrad region. The Pavlov statistical department created a table with stratification on gender distribution, viral load, and CD4 cell count. We stratified participants according to gender, viral load, and CD4 cells per μL, and randomly assigned (1:1) them to addiction treatment with a naltrexone implant and oral naltrexone placebo (implant group) or oral naltrexone and placebo implant (oral group). The primary outcome was plasma viral load of less than 400 copies per mL at 24 weeks and 48 weeks. We inclu...
Source: The Lancet HIV - Category: Infectious Diseases Source Type: research