Directly Observed Antiretroviral Therapy Among Active Drug Users

March 27, 2020 updated by: Yale University
The goal of this randomized, controlled trial is to compare the effectiveness of a community-based program of providing supervised antiretroviral therapy to HIV-positive drug users, compared to having the patients take the medicines on their own.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Highly active antiretroviral therapy (HAART) has dramatically reduced morbidity and mortality from HIV disease, but these benefits have not been conferred equally among all patient populations. Injection drug users (IDUs) have shown particularly less favorable outcomes, with HIV progression remaining at high levels, and IDU remains a significant risk behavior for the spread of HIV worldwide, with explosive epidemics in Eastern Europe, Russia, and Southeast Asia. It is therefore essential to develop and test strategies of HIV treatment that optimize outcomes for this population, in order to reduce morbidity and mortality and to curb secondary transmission.

Directly observed therapy (DOT) for tuberculosis has resulted in impressive improvements in adherence and clinical response and marked reductions in the development of resistance. The time-limited treatment of tuberculosis, the inherently different transmission patterns of tuberculosis and HIV, and the complexity of antiretroviral therapy have raised concerns about translating the DOT model to HIV. Successful, but non-comparative demonstration programs of directly administered antiretroviral therapy (DAART) have been implemented in methadone maintenance programs, community-based settings, skilled nursing facilities, and in prisons. None of these, however, have targeted active drug users or used a prospective, randomized controlled trial (RCT) design to rigorously determine the efficacy of DAART as an intervention to improve HIV outcomes among active drug users. One RCT of DAART recently failed to demonstrate an impact on virological outcomes among low-income HIV+ patients, but these results are unlikely to be applicable to IDUs or other populations with demonstrated problematic adherence.

We therefore conducted the first randomized controlled trial to address this question, consisting of six months of DAART versus self-administered therapy (SAT) among active drug users in a community setting. The objective was to determine the potential efficacy of a six-month DAART program on HIV infection, using surrogate markers of HIV- RNA levels and CD4+ T lymphocyte counts.

Study Type

Interventional

Enrollment

125

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University School Of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. being HIV seropositive;
  2. being eligible for and/or being prescribed HAART
  3. living within the city of New Haven
  4. actively using heroin and/or cocaine in the previous six months
  5. receiving no more than a twice-daily regimen

Exclusion Criteria:

Not meeting inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Virological Success, defined as greater than 1 Log HIV-1 Copies/mL reduction or Viral Load Less than 400 copies/mL at the end of six months on the intervention.

Secondary Outcome Measures

Outcome Measure
Mean change in HIV-1 viral load from baseline to six months at the end of the intervention.
Virological Success at six months following the termination of the intervention.
3-Day Recall measures of adherence at the end of six months on the intervention.
Mean change in HIV-1 viral load from baseline six months following the termination of the intervention.
Mean change in CD4+ T cells from baseline to the end of six months on the intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Investigators

  • Principal Investigator: Frederick L Altice, M.D., Yale AIDS Program
  • Principal Investigator: Gerald H Friedland, Yale AIDS Program

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2001

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

August 21, 2006

First Submitted That Met QC Criteria

August 21, 2006

First Posted (Estimate)

August 22, 2006

Study Record Updates

Last Update Posted (Actual)

March 31, 2020

Last Update Submitted That Met QC Criteria

March 27, 2020

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0003011701
  • R01DA013805 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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