Directly Administered Antiretroviral Therapy for HIV-Infected Individuals in Opioid Treatment Programs: Results from a Randomized Clinical Trial

Gregory M Lucas, Bernadette Anna Mullen, Noya Galai, Richard D Moore, Katie Cook, Mary Elizabeth McCaul, Sheldon Glass, Krisann K. Oursler, Cynthia S Rand

Research output: Contribution to journalArticle

Abstract

Background:Data regarding the efficacy of directly administered antiretroviral therapy (DAART) are mixed. Opioid treatment programs (OTPs) provide a convenient framework for DAART. In a randomized controlled trial, we compared DAART and self-administered therapy (SAT) among HIV-infected subjects attending five OTPs in Baltimore, MD.Methods:HIV-infected individuals attending OTPs were eligible if they were not taking antiretroviral therapy (ART) or were virologically failing ART at last clinical assessment. In subjects assigned to DAART, we observed one ART dose per weekday at the OTP for up to 12 months. SAT subjects administered ART at home. The primary efficacy comparison was the between-arm difference in the average proportions with HIV RNA 10 HIV RNA from baseline, opportunistic conditions, hospitalizations, mortality, or the development of new drug resistance mutations.Conclusions:In this randomized trial, we found little evidence that DAART provided clinical benefits compared to SAT among HIV-infected subjects attending OTPs.Trial Registration:ClinicalTrails.gov NCT00279110.

Original languageEnglish (US)
Article numbere68286
JournalPLoS One
Volume8
Issue number7
DOIs
StatePublished - Jul 16 2013

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randomized clinical trials
narcotics
Opioid Analgesics
Randomized Controlled Trials
HIV
therapeutics
RNA
Therapeutics
new drugs
Pharmaceutical Preparations
drug resistance
Baltimore

ASJC Scopus subject areas

  • Agricultural and Biological Sciences(all)
  • Biochemistry, Genetics and Molecular Biology(all)
  • Medicine(all)

Cite this

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title = "Directly Administered Antiretroviral Therapy for HIV-Infected Individuals in Opioid Treatment Programs: Results from a Randomized Clinical Trial",
abstract = "Background:Data regarding the efficacy of directly administered antiretroviral therapy (DAART) are mixed. Opioid treatment programs (OTPs) provide a convenient framework for DAART. In a randomized controlled trial, we compared DAART and self-administered therapy (SAT) among HIV-infected subjects attending five OTPs in Baltimore, MD.Methods:HIV-infected individuals attending OTPs were eligible if they were not taking antiretroviral therapy (ART) or were virologically failing ART at last clinical assessment. In subjects assigned to DAART, we observed one ART dose per weekday at the OTP for up to 12 months. SAT subjects administered ART at home. The primary efficacy comparison was the between-arm difference in the average proportions with HIV RNA 10 HIV RNA from baseline, opportunistic conditions, hospitalizations, mortality, or the development of new drug resistance mutations.Conclusions:In this randomized trial, we found little evidence that DAART provided clinical benefits compared to SAT among HIV-infected subjects attending OTPs.Trial Registration:ClinicalTrails.gov NCT00279110.",
author = "Lucas, {Gregory M} and Mullen, {Bernadette Anna} and Noya Galai and Moore, {Richard D} and Katie Cook and McCaul, {Mary Elizabeth} and Sheldon Glass and Oursler, {Krisann K.} and Rand, {Cynthia S}",
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AU - Mullen, Bernadette Anna

AU - Galai, Noya

AU - Moore, Richard D

AU - Cook, Katie

AU - McCaul, Mary Elizabeth

AU - Glass, Sheldon

AU - Oursler, Krisann K.

AU - Rand, Cynthia S

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