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Directly Administered HIV Therapy in Methadone Clinics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00279110
Recruitment Status : Completed
First Posted : January 19, 2006
Last Update Posted : April 15, 2015
National Institute on Drug Abuse (NIDA)
Information provided by:
Johns Hopkins University

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 take HIV medications on their own.

Condition or disease Intervention/treatment Phase
HIV Infections Heroin Dependence Behavioral: Directly administered antiretroviral therapy (DAART) Phase 2 Phase 3

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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Directly Administered vs. Self-administered Antiretroviral Therapy in Methadone Clinics
Study Start Date : April 2006
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Heroin
Drug Information available for: Methadone

Arm Intervention/treatment
Experimental: A Behavioral: Directly administered antiretroviral therapy (DAART)
Participants are observed taking HIV medications on days when they receive opioid agonist therapy.

No Intervention: B

Primary Outcome Measures :
  1. HIV RNA < 50 c/mL [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Log10 change in HIV RNA from baseline [ Time Frame: 12 months ]
  2. HIV RNA < 50 c/mL 6 mos. after intervention [ Time Frame: 18 months ]
  3. Log10 change in HIV RNA from baseline 6 months post intervention [ Time Frame: 18 months ]
  4. Change in CD4 cell count from baseline [ Time Frame: 18 months ]
  5. ART utilization [ Time Frame: 12 months ]
  6. Development of antiretroviral resistance [ Time Frame: 12 months ]
  7. Retention to substance abuse treatment [ Time Frame: 12 months ]
  8. Urine drug screen positivity in follow-up [ Time Frame: 12 months ]
  9. Electronically monitored adherence [ Time Frame: 2 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  1. Need to use ART dosed more frequently than twice daily,
  2. Need to use a liquid preparation of antiretroviral medication,
  3. Documented triple-class antiretroviral resistance (defined below),
  4. Participation in another study or program that includes directly observed therapy.
  5. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00279110

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United States, Maryland
Baltimore VA Drug Dependency Program
Baltimore, Maryland, United States, 21201
Program for Alcohol and Other Drug Dependencies
Baltimore, Maryland, United States, 21205
Man Alive, Inc.
Baltimore, Maryland, United States, 21218
New Hope Treatment Center
Baltimore, Maryland, United States, 21223
Day Break Methadone Clinic
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
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Principal Investigator: Gregory M. Lucas, MD, PhD Johns Hopkins University
Publications of Results:
Other Publications:
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Responsible Party: Gregory M. Lucas, MD PhD, Johns Hopkins University Identifier: NCT00279110    
Other Study ID Numbers: R01DA018577 ( U.S. NIH Grant/Contract )
First Posted: January 19, 2006    Key Record Dates
Last Update Posted: April 15, 2015
Last Verified: May 2011
Keywords provided by Johns Hopkins University:
Antiretroviral therapy
Heroin dependence
Additional relevant MeSH terms:
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Heroin Dependence
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents