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

Phase 2

Withdrawn

• Conditions: HIV Infections; Heroin Dependence
• Interventions: Behavioral: Directly Administered Antiretroviral Therapy (DAART); Behavioral: SAT

• Registration Number: NCT00709007
• Lead Sponsor: Johns Hopkins University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-01
• Study First Submitted QC: 2008-07-01
• Study First Posted: 2008-07-03
• Status Verified: 2009-03
• Primary Completion: 2010-07
• Study Completion: 2011-07
• Last Update Submitted: 2015-04-14
• Last Update Posted: 2015-04-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. 18 years of age or older

2. Provide written informed consent

3. Permanent residence should be less than or equal to 15 kms (9.5 miles) from the YRGCSAR clinic

4. Be an injection drug user (by self-report)

5. Satisfy criteria for opioid dependence as per the DSM-IV criteria (see Appendix)

6. Urine screening must test positive for presence of opioids

7. Documented evidence of HIV infection (double ELISA: Murex HIV-1.2.O, Abbott Murex, UK and Vironostika® HIV Uni-form II Ag/Ab, Biomérieux, The Netherlands)

8. Be ART naïve (by self-report)

9. If female of childbearing potential (all of the following)

   • Have a negative urine pregnancy test
   • Be willing to use barrier based or oral contraceptive for the duration of the study if sexually active.

10. Satisfy Indian National Guidelines for initiation of HAART (any of the following)

    • Absolute CD4+ count < 200 cells/ µl
    • AIDS-defining illness with any CD4+ count
    • Absolute CD4+ count between 200 - 350 cell/ µl with HIV-related symptoms

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Exclusion Criteria

1. Requires a liquid preparation of ART or ART needs to be dosed more than twice daily
2. Indicates an intention to migrate in the next 48 weeks
3. Clinical or radiological signs of active tuberculosis
4. Any medical or psychiatric condition that the study physician believes to be a contraindication to study participation.
5. Enrolled in another HIV treatment program

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DAART	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.
SAT	SAT	Participants take their HIV medications on their own but visit the clinic for opioid agonist substitution therapy.

Primary Outcome Measures

Name	Time	Method
HIV RNA < 400 copies/ml	48 weeks

Secondary Outcome Measures

Name	Time	Method
Incidence of antiretroviral drug resistance	48 weeks
Change in absolute CD4+ count from baseline	48 weeks
Incidence of mortality and/or AIDS-defining illnesses	48 weeks

Trial Locations

Locations (1)

YR Gaitonde Centre for Substance Abuse-Related Research (YRGCSAR); 🇮🇳 Chennai, Tamil Nadu, India