Last updated on November 2018

Adherence to HIV Therapy in Heroin Addicts


Brief description of study

This study will obtain pilot data on the impact oral naltrexone 50 mg/day vs. a sustained-release naltrexone implant on response to antiretroviral therapy (ART) in opioid addicted patients beginning ART in St. Petersburg, Russia.

Detailed Study Description

The study will randomize, in a 1:1 ratio, 260 recently detoxified opioid addicts beginning ART to a 48-week course of biweekly drug counseling with either oral naltrexone 50 mg/day + placebo naltrexone implant, or placebo tablet + naltrexone implant. Approximate balanced randomization will be achieved by using an urn randomization design within each set of sites based in two baseline characteristics: (1) viral load >100,000 copies/<100,000 copies, and (2) CDF count >50/>50 copies. The primary outcome will be the response to ART as measured by reduction in viral load at 24 and 48 weeks.

Clinical Study Identifier: NCT01101815

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Evgeny Krupitsky, MD

Leningrad Region Addiction Treatment
Leningrad Region, Russian Federation

Evgeny Krupitsky, MD

Leningrad Region AIDS Center
St. Petersburg, Russian Federation

Recruitment Status: Closed


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