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HIV InfectionsPhase 2/3NCT00279110

Directly Administered HIV Therapy in Methadone Clinics

A Phase 2/3 study testing Directly administered antiretroviral therapy (DAART) in people with HIV Infections and Heroin Dependence, run by Johns Hopkins University at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections, Heroin Dependence
What is being tested?
Directly administered antiretroviral therapy (DAART)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
107 participants
Where
5 sitesUnited States
Study dates
Apr 2006to May 2011
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Baltimore VA Drug Dependency Program

    Baltimore, Maryland, 21201

  • Program for Alcohol and Other Drug Dependencies

    Baltimore, Maryland, 21205

  • Man Alive, Inc.

    Baltimore, Maryland, 21218

  • New Hope Treatment Center

    Baltimore, Maryland, 21223

  • Day Break Methadone Clinic

    Baltimore, Maryland, 21225

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Directly administered antiretroviral therapy (DAART)
Keywords
HIV, Antiretroviral therapy, Heroin dependence, Methadone, Buprenorphine
Medical subject headings
HIV Infections, Heroin Dependence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Directly administered antiretroviral therapy (DAART)Behavioural

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

Study groups in NCT00279110
Study groupRoleWhat they receive
AExperimentalNot described
Receives: Behavioral: Directly administered antiretroviral therapy (DAART)
BNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HIV RNA < 50 c/mL

    Measured: 12 months

Secondary outcomes (9)

  1. Log10 change in HIV RNA from baseline

    Measured: 12 months

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

    Measured: 18 months

  3. Log10 change in HIV RNA from baseline 6 months post intervention

    Measured: 18 months

  4. Change in CD4 cell count from baseline

    Measured: 18 months

  5. ART utilization

    Measured: 12 months

  6. Development of antiretroviral resistance

    Measured: 12 months

  7. Retention to substance abuse treatment

    Measured: 12 months

  8. Urine drug screen positivity in follow-up

    Measured: 12 months

  9. Electronically monitored adherence

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2006 (estimated)
  2. Study startApr 2006
  3. Primary completionMay 2011
  4. Study completionMay 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
107 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00279110
Sponsor's protocol ID
R01DA018577
Status last verified
May 2011
First submitted
17 Jan 2006
Last updated
15 Apr 2015
Results posted
No

Publications

  • 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.

    PubMed 21324133

  • 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.

    PubMed 23874575

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Directly administered antiretroviral therapy (DAART) in people with HIV Infections and Heroin Dependence, run by Johns Hopkins University at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HIV RNA < 50 c/mL (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00279110, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2015.

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