Directly Administered HIV Therapy in Methadone Clinics - Full Text View

Sponsor:	Johns Hopkins University
Collaborator:	National Institute on Drug Abuse (NIDA)
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00279110

Purpose

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
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

Resource links provided by NLM:

MedlinePlus related topics: AIDS Heroin

Drug Information available for: Methadone Methadone hydrochloride

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

HIV RNA < 50 c/mL [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Log10 change in HIV RNA from baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]
HIV RNA < 50 c/mL 6 mos. after intervention [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Log10 change in HIV RNA from baseline 6 months post intervention [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Change in CD4 cell count from baseline [ Time Frame: 18 months ] [ Designated as safety issue: No ]
ART utilization [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Development of antiretroviral resistance [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Retention to substance abuse treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Urine drug screen positivity in follow-up [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Electronically monitored adherence [ Time Frame: 2 months ] [ Designated as safety issue: No ]

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
A: Experimental	Behavioral: Directly administered antiretroviral therapy (DAART) Participants are observed taking HIV medications on days when they receive opioid agonist therapy.
B: No Intervention	Behavioral: Self-administered therapy (SAT) Participants take HIV medications on their own at home.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00279110

Contacts

Contact: B. Anna Mullen, RN

410-502-5088

bmullen1@jhmi.edu

Locations

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

Sponsors and Collaborators

Johns Hopkins University

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Gregory M. Lucas, MD, PhD

Johns Hopkins University

More Information

No publications provided

Responsible Party:	Johns Hopkins University ( Gregory M. Lucas, MD PhD )
Study ID Numbers:	R01-DA018577
Study First Received:	January 17, 2006
Last Updated:	April 28, 2009
ClinicalTrials.gov Identifier:	NCT00279110 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Johns Hopkins University:

HIV
Antiretroviral therapy
Heroin dependence
Methadone
Buprenorphine

Additional relevant MeSH terms:

Respiratory System Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Physiological Effects of Drugs
Disorders of Environmental Origin
Infection
Opioid-Related Disorders
Sensory System Agents
Mental Disorders
Therapeutic Uses
Substance-Related Disorders
Analgesics
Retroviridae Infections
Analgesics, Opioid
RNA Virus Infections

Immune System Diseases
Heroin Dependence
Acquired Immunodeficiency Syndrome
Central Nervous System Depressants
Narcotics
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
Methadone
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Peripheral Nervous System Agents
Antitussive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009