NCT00279110

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for phase_2 hiv-infections

Timeline
Completed

Started Apr 2006

Longer than P75 for phase_2 hiv-infections

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 19, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2006

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

April 15, 2015

Status Verified

May 1, 2011

Enrollment Period

5.1 years

First QC Date

January 17, 2006

Last Update Submit

April 14, 2015

Conditions

HIV InfectionsHeroin Dependence

Keywords

HIVAntiretroviral therapyHeroin dependenceMethadoneBuprenorphine

Outcome Measures

Primary Outcomes (1)

  • HIV RNA < 50 c/mL

    12 months

Secondary Outcomes (9)

  • Log10 change in HIV RNA from baseline

    12 months

  • HIV RNA < 50 c/mL 6 mos. after intervention

    18 months

  • Log10 change in HIV RNA from baseline 6 months post intervention

    18 months

  • Change in CD4 cell count from baseline

    18 months

  • ART utilization

    12 months

  • +4 more secondary outcomes

Study Arms (2)

A

EXPERIMENTAL
Behavioral: Directly administered antiretroviral therapy (DAART)

B

NO INTERVENTION

Interventions

Directly administered antiretroviral therapy (DAART)BEHAVIORAL

Participants are observed taking HIV medications on days when they receive opioid agonist therapy.

A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Baltimore VA Drug Dependency Program

Baltimore, Maryland, 21201, United States

Location

Program for Alcohol and Other Drug Dependencies

Baltimore, Maryland, 21205, United States

Location

Man Alive, Inc.

Baltimore, Maryland, 21218, United States

Location

New Hope Treatment Center

Baltimore, Maryland, 21223, United States

Location

Day Break Methadone Clinic

Baltimore, Maryland, 21225, United States

Location

Related Publications (2)

  • Mullen BA, Cook K, Moore RD, Rand C, Galai N, McCaul ME, Glass S, Oursler KK, Lucas GM. Study design and participant characteristics of a randomized controlled trial of directly administered antiretroviral therapy in opioid treatment programs. BMC Infect Dis. 2011 Feb 15;11:45. doi: 10.1186/1471-2334-11-45.

    PMID: 21324133BACKGROUND

  • Lucas GM, Mullen BA, Galai N, Moore RD, Cook K, McCaul ME, Glass S, Oursler KK, Rand C. Directly administered antiretroviral therapy for HIV-infected individuals in opioid treatment programs: results from a randomized clinical trial. PLoS One. 2013 Jul 16;8(7):e68286. doi: 10.1371/journal.pone.0068286. Print 2013.

    PMID: 23874575RESULT

MeSH Terms

Conditions

HIV InfectionsHeroin Dependence

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesOpioid-Related DisordersNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Gregory M. Lucas, MD, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 17, 2006

First Posted

January 19, 2006

Study Start

April 1, 2006

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

April 15, 2015

Record last verified: 2011-05

Locations

US(5)