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Adherence to HIV Therapy in Heroin Addicts

2014-08-27 03:14:39 | BioPortfolio

Summary

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.

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.

Study Design

Allocation: Randomized, Control: Active Control, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

HIV

Intervention

Oral Naltrexone (ON), Implantable Naltrexone (IN)

Location

Leningrad Region Addiction Treatment
Leningrad Region
Russian Federation
188661

Status

Not yet recruiting

Source

National Institute on Drug Abuse (NIDA)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:39-0400

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