Directly Administered HIV Therapy in Methadone Clinics

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00279110
First received: January 17, 2006
Last updated: May 4, 2011
Last verified: May 2011

January 17, 2006
May 4, 2011
April 2006
May 2011   (final data collection date for primary outcome measure)
HIV RNA < 50 c/mL [ Time Frame: 12 months ] [ Designated as safety issue: No ]
HIV RNA < 50 c/mL at 3, 6, and 12 months
Complete list of historical versions of study NCT00279110 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Log10 change in HIV RNA from baseline at 3, 6 and 12 months
  • HIV RNA < 50 c/mL at 18 months (6 mos. after intervention)
  • Log10 change in HIV RNA from baseline at 18 months
  • Change in CD4 cell count from baseline at 3, 6, 12, and 18 months
  • ART utilization during 12-month intervention
  • Development of antiretroviral resistance
  • Retention to substance abuse treatment
  • Urine drug screen positivity in follow-up
  • Electronically monitored adherence
Not Provided
Not Provided
 
Directly Administered HIV Therapy in Methadone Clinics
Directly Administered vs. Self-administered Antiretroviral Therapy in Methadone Clinics

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infections
  • Heroin Dependence
  • Behavioral: Directly administered antiretroviral therapy (DAART)
    Participants are observed taking HIV medications on days when they receive opioid agonist therapy.
  • Behavioral: Self-administered therapy (SAT)
    Participants take HIV medications on their own at home.
  • Experimental: A
    Intervention: Behavioral: Directly administered antiretroviral therapy (DAART)
  • No Intervention: B
    Intervention: Behavioral: Self-administered therapy (SAT)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
107
May 2011
May 2011   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00279110
R01-DA018577
Not Provided
Gregory M. Lucas, MD PhD, Johns Hopkins University
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Gregory M. Lucas, MD, PhD Johns Hopkins University
Johns Hopkins University
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP