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

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ClinicalTrials.gov Identifier: NCT00709007
Recruitment Status : Withdrawn (No participants satisfied eligibility criteria and were enrolled into the study since July 2008.)
First Posted : July 3, 2008
Last Update Posted : April 15, 2015
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by:
Johns Hopkins University

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV Infections Heroin Dependence Behavioral: Directly Administered Antiretroviral Therapy (DAART) Behavioral: SAT Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating the Role of Directly Administered Antiretroviral Therapy (DAART) in Conjunction With Opiate Substitution in Delivery of Highly Active Antiretroviral Therapy to HIV-1-infected Injecting Drug Users (IDUs) in Chennai, India
Study Start Date : July 2008
Estimated Primary Completion Date : July 2010
Estimated Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Abuse HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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: 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.
Active Comparator: SAT
Participants take their HIV medications on their own but visit the clinic for opioid agonist substitution therapy.
 Behavioral: SAT
Participants take their HIV medications by themselves.


Outcome Measures
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Primary Outcome Measures :
  1. HIV RNA < 400 copies/ml [ Time Frame: 48 weeks ]

Secondary Outcome Measures :
  1. Incidence of mortality and/or AIDS-defining illnesses [ Time Frame: 48 weeks ]
  2. Change in absolute CD4+ count from baseline [ Time Frame: 48 weeks ]
  3. Incidence of antiretroviral drug resistance [ Time Frame: 48 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00709007


Locations
India
YR Gaitonde Centre for Substance Abuse-Related Research (YRGCSAR)
Chennai, Tamil Nadu, India, 600013
Sponsors and Collaborators
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Gregory M Lucas, MD,PhD Johns Hopkins University School of Medicine, USA
More Information
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Responsible Party: Gregory M Lucas, Johns Hopkins University School of Medicine
ClinicalTrials.gov Identifier: NCT00709007     History of Changes
Other Study ID Numbers: R01DA018577-03S1 ( U.S. NIH Grant/Contract )
First Posted: July 3, 2008    Key Record Dates
Last Update Posted: April 15, 2015
Last Verified: March 2009

Additional relevant MeSH terms:
HIV Infections
Heroin Dependence
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
 Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders