Status:
WITHDRAWN
Directly Administered Antiretroviral Therapy (DAART) Among HIV-1infected Injecting Drug Users (IDUs) in Chennai, India
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
HIV Infections
Heroin Dependence
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 h...
Eligibility Criteria
Inclusion
- 18 years of age or older
- Provide written informed consent
- Permanent residence should be less than or equal to 15 kms (9.5 miles) from the YRGCSAR clinic
- Be an injection drug user (by self-report)
- Satisfy criteria for opioid dependence as per the DSM-IV criteria (see Appendix)
- Urine screening must test positive for presence of opioids
- 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)
- Be ART naïve (by self-report)
- 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.
- 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
- Requires a liquid preparation of ART or ART needs to be dosed more than twice daily
- Indicates an intention to migrate in the next 48 weeks
- Clinical or radiological signs of active tuberculosis
- Any medical or psychiatric condition that the study physician believes to be a contraindication to study participation.
- Enrolled in another HIV treatment program
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00709007
Start Date
July 1 2008
End Date
July 1 2011
Last Update
April 15 2015
Active Locations (1)
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1
YR Gaitonde Centre for Substance Abuse-Related Research (YRGCSAR)
Chennai, Tamil Nadu, India, 600013