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Sponsors and Collaborators: |
Johns Hopkins University National Institute on Drug Abuse (NIDA) |
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Information provided by: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT00279110 |
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 | Intervention | Phase |
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HIV Infections Heroin Dependence |
Behavioral: Directly administered antiretroviral therapy (DAART) Behavioral: Self-administered therapy (SAT) |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Directly Administered vs. Self-Administered Antiretroviral Therapy in Methadone Clinics |
Estimated Enrollment: | 200 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental |
Behavioral: Directly administered antiretroviral therapy (DAART)
Participants are observed taking HIV medications on days when they receive opioid agonist therapy.
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B: No Intervention |
Behavioral: Self-administered therapy (SAT)
Participants take HIV medications on their own at home.
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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:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Triple-class antiretroviral resistance will be defined according 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.
Contact: B. Anna Mullen, RN | 410-502-5088 | bmullen1@jhmi.edu |
United States, Maryland | |
Program for Alcohol and Other Drug Dependencies | Recruiting |
Baltimore, Maryland, United States, 21205 | |
Contact: Tracey Whoolery, MA 410-614-2026 twhooler@jhmi.edu | |
Principal Investigator: Gregory Lucas, MD, PhD | |
Day Break Methadone Clinic | Recruiting |
Baltimore, Maryland, United States, 21225 | |
Contact: Helen Norman, LPN helencnorman@msn.com | |
Principal Investigator: Sheldon Glass, MD | |
New Hope Treatment Center | Terminated |
Baltimore, Maryland, United States, 21223 | |
Man Alive, Inc. | Recruiting |
Baltimore, Maryland, United States, 21218 | |
Contact: April Stokes 410-837-4292 ext 1311 astokes1@jhmi.edu | |
Principal Investigator: Gregory Lucas, MD, PhD | |
Baltimore VA Drug Dependency Program | Recruiting |
Baltimore, Maryland, United States, 21201 | |
Contact: Walter Williams 410-215-1079 | |
Principal Investigator: Kris Ann Oursler, MD, ScM |
Principal Investigator: | Gregory M. Lucas, MD, PhD | Johns Hopkins University |
Responsible Party: | Johns Hopkins University ( Gregory M. Lucas, MD PhD ) |
Study ID Numbers: | R01-DA018577 |
Study First Received: | January 17, 2006 |
Last Updated: | July 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00279110 |
Health Authority: | United States: Institutional Review Board |
HIV Antiretroviral therapy Heroin dependence Methadone Buprenorphine |
Sexually Transmitted Diseases, Viral Heroin Heroin Dependence Acquired Immunodeficiency Syndrome Disorders of Environmental Origin Opioid-Related Disorders Immunologic Deficiency Syndromes Naphazoline Virus Diseases Oxymetazoline |
Methadone Buprenorphine Guaifenesin Phenylephrine HIV Infections Mental Disorders Sexually Transmitted Diseases Substance-Related Disorders Phenylpropanolamine Retroviridae Infections |
Respiratory System Agents RNA Virus Infections Slow Virus Diseases Immune System Diseases Physiological Effects of Drugs Central Nervous System Depressants Narcotics Infection Pharmacologic Actions |
Sensory System Agents Therapeutic Uses Lentivirus Infections Peripheral Nervous System Agents Analgesics Antitussive Agents Central Nervous System Agents Analgesics, Opioid |