Directly Administered HIV Therapy in Methadone Clinics

Completed · Phase 2/Phase 3

Conditions studied: HIV Infections, Heroin Dependence

In brief

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.

Key facts

Study ID

NCT00279110

Run by

Johns Hopkins University

People needed

107

Starts

2006-04-01

Expected to finish

2011-05-01

Last updated by the study team

2015-04-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Eighteen years of age or older
• Documented serologic evidence of HIV infection (positive ELISA and Western blot)
• Identifiable medical provider, who is responsible for managing HIV treatment
• Proof that ART has been prescribed and that patient has prescription medication coverage
• Nadir CD4+ cell count < 350/mm3 or off-treatment HIV RNA > 55,000 copies/ml if asymptomatic and ART naive
• Current plasma HIV RNA > 500 copies/ml
• Initiating ART for first time, reinitiating therapy after stopping, or changing therapy due to virologic failure
• ART with at least 3 agents, including a protease inhibitor, a non-nucleoside reverse transcriptase inhibitor, or abacavir
• Methadone or buprenorphine maintenance therapy > 3 weeks, with no planned detoxification

You may not qualify if…

• Need to use ART dosed more frequently than twice daily,
• Need to use a liquid preparation of antiretroviral medication,
• Documented triple-class antiretroviral resistance (defined below),
• Participation in another study or program that includes directly observed therapy.
• Use of ART regimens that are expressly discouraged in DHHS HIV clinical care guidelines
• Triple-class antiretroviral resistance will be defined according to IAS-USA interpretive guidelines: NRTI class - 3 thymidine or non-thymidine-associated mutations (excluding the M184V mutation) or a multi-nucleoside resistance mutation in reverse transcriptase; PI class - 3 protease mutations, including 1 primary mutation; NNRTI class - 1 primary (K103N or Y188L) or 2 secondary NNRTI-associated mutations in reverse transcriptase.

Where it is running

• Baltimore VA Drug Dependency Program — Baltimore, Maryland, United States
• Program for Alcohol and Other Drug Dependencies — Baltimore, Maryland, United States
• Man Alive, Inc. — Baltimore, Maryland, United States
• New Hope Treatment Center — Baltimore, Maryland, United States
• Day Break Methadone Clinic — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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