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Directly Administered Antiretroviral Therapy (DAART) Among HIV-1infected Injecting Drug Users (IDUs) in Chennai, India (DAART+)
This study is not yet open for participant recruitment.
Verified by Johns Hopkins University, July 2008
Sponsors and Collaborators: Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Information provided by: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00709007
  Purpose

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 Intervention Phase
HIV Infections
Heroin Dependence
 Behavioral: Directly Administered Antiretroviral Therapy (DAART)
Behavioral: SAT
 Phase II
Phase III

MedlinePlus related topics: AIDS Heroin
Drug Information available for: Buprenorphine Buprenorphine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • HIV RNA < 400 copies/ml [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of mortality and/or AIDS-defining illnesses [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Change in absolute CD4+ count from baseline [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Incidence of antiretroviral drug resistance [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: July 2008
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
DAART: Experimental
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.
SAT: Active Comparator
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)

    1. Have a negative urine pregnancy test
    2. 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)

    1. Absolute CD4+ count < 200 cells/ µl
    2. AIDS-defining illness with any CD4+ count
    3. 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00709007

Locations
India, Tamil Nadu
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

Responsible Party: Johns Hopkins University School of Medicine ( Gregory M Lucas )
Study ID Numbers: R01-DA018577-03S1
Study First Received: July 1, 2008
Last Updated: July 1, 2008
ClinicalTrials.gov Identifier: NCT00709007  
Health Authority: India: Indian Council of Medical Research;   India: Institutional Review Board;   United States: Institutional Review Board

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Heroin Dependence
Acquired Immunodeficiency Syndrome
Disorders of Environmental Origin
Opioid-Related Disorders
Immunologic Deficiency Syndromes
Virus Diseases
 Buprenorphine
HIV Infections
Mental Disorders
Sexually Transmitted Diseases
Substance-Related Disorders
Retroviridae Infections

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 14, 2009



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