Directly Administered HIV Therapy in Methadone Clinics

HIV Infections Clinical Trial

Official title: Directly Administered vs. Self-administered Antiretroviral Therapy in Methadone Clinics

Status Completed

Clinical Trial Summary

The purpose of this study is to determine whether providing directly administered antiretroviral therapy to HIV-infected who receive methadone therapy leads to better treatment outcomes than if they take HIV medications on their own.

Clinical Trial Description

We propose to conduct a randomized, unblinded, clinical trial of a medication adherence intervention in opioid-dependent, HIV-infected participants who are initiating new antiretroviral therapy, and who receive opioid agonist maintenance therapy with methadone or buprenorphine in opioid treatment programs (OTPs) in Baltimore, MD. Randomization will be stratified by study site and prior antiretroviral exposure. Two hundred participants will be randomly assigned 1:1 self-administered antiretroviral therapy (SAT) or directly administered antiretroviral therapy (DAART). Subjects assigned to DAART will take morning doses of antiretroviral therapy with a nurse or medical assistant in a private room at the OTP. DAART subjects will be transferred to self-administered therapy after 12 months. This is a 5 year study and participants will be enrolled between month 6 and month 42 of the study. The maximum follow-up for individual participants will be 18 months. Based on our pilot experience we anticipate 50% of subjects will be women, 80% African American, with a median age of 44 years. The following outcomes will be compared in the two study arms:

• Suppression of the viral load (primary outcome)

• Changes in CD4+ cell counts

• The development of antiretroviral drug resistance

• Retention to opioid agonist maintenance therapy, urine toxicology screens for drugs of abuse, and self-reported drug and alcohol use

• Self-reported adherence with therapy, retention to ART, and clinical and psychosocial moderators of adherence

• Electronically monitored medication adherence, using MEMS caps, in the first 2 months of the study

Outcomes data will be obtained at study assessment visits at baseline, 3 months, 6 months, 12 months, and 18 months. Participants will provide contact information, take an interviewer-administered survey, and provide blood and urine samples at study assessment visits. MEMS cap data will be captured at 1 month and 2 months. Subjects will be compensated for successful completion of study assessment visits and MEMS interrogations. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heroin Dependence
• HIV Infections

• NCT number: NCT00279110
• Study type: Interventional
• Source: Johns Hopkins University
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: April 2006
• Completion date: May 2011