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Directly Administered Antiretroviral Therapy (DAART) Among HIV-1infected Injecting Drug Users (IDUs) in Chennai, India

NCT00709007 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2015-04-15

No results posted yet for this study

Summary

Though the HIV epidemic in India is predominantly among heterosexual populations, it is estimated that there are approximately 1.1 million injection drug users (IDUs) in India with HIV prevalence as high as 64% among IDUs in certain cities. In April 2004, the government of India launched a free-antiretroviral therapy roll-out program aimed at initiating 100,000 persons on HAART. Similar guidelines are currently being followed for the delivery and choice of HAART for IDU and non-IDU populations. However, IDUs have certain issues that complicate the delivery of HAART that need to be addressed by delivery programs such as delayed access to care, poor perceived adherence, and more rapid disease progression. This proposal will assess the feasibility and effectiveness of directly administered antiretroviral therapy (DAART) in conjunction with opioid substitution as a mode of delivery of HAART to IDUs in Chennai, India. To evaluate this objective we will conduct a randomized controlled pilot study of DAART vs self-administered therapy (SAT) among 100 HIV-1 infected treatment naïve IDUs who are enrolled in an opioid substitution program in Chennai and compare the following outcomes between the two arms: Primary Endpoint: Proportion of participants with viral load (VL) \<400 copies/ml at 24 and 48 weeks; Secondary Endpoints: (1) Incidence of mortality and AIDS-defining illnesses at 24 and 48 weeks, (2) Changes in absolute CD4+ count from baseline at 24 and 48 weeks, and (3) Incidence of antiretroviral drug resistance at 24 and 48 weeks. Intention-to-treat analyses will be used. The study objective is in line with the priority areas identified in the Indian National AIDS Control Program Phase III (NACP III) and the results of this study will help inform the government of India on appropriate modes of delivery of HAART to IDUs. This study will also be among the first studies to be conducted in India to evaluate two different modes of delivery of HAART to IDUs.

Conditions

  • HIV Infections
  • Heroin Dependence

Interventions

BEHAVIORAL

Directly Administered Antiretroviral Therapy (DAART)

Participants are observed taking HIV medications by study staff on days when they receive opioid agonist therapy (sub-lingual buprenorphine) at the clinic.

BEHAVIORAL

SAT

Participants take their HIV medications by themselves.

Sponsors & Collaborators

Principal Investigators

  • Gregory M Lucas, MD,PhD · Johns Hopkins University School of Medicine, USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2010-07-31
Completion
2011-07-31

Countries

  • India

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00709007 on ClinicalTrials.gov