Status:
COMPLETED
Directly Administered HIV Therapy in Methadone Clinics
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
HIV Infections
Heroin Dependence
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 t...
Detailed 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 w...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT00279110
Start Date
April 1 2006
End Date
May 1 2011
Last Update
April 15 2015
Active Locations (5)
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1
Baltimore VA Drug Dependency Program
Baltimore, Maryland, United States, 21201
2
Program for Alcohol and Other Drug Dependencies
Baltimore, Maryland, United States, 21205
3
Man Alive, Inc.
Baltimore, Maryland, United States, 21218
4
New Hope Treatment Center
Baltimore, Maryland, United States, 21223