Directly Administered Antiretroviral Therapy (DAART) Among HIV-1infected Injecting Drug Users (IDUs) in Chennai, India (DAART+)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
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Withdrawn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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections Heroin Dependence | Behavioral: Directly Administered Antiretroviral Therapy (DAART) Behavioral: SAT | Phase 2 Phase 3 |
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 |
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.
|
- HIV RNA < 400 copies/ml [ Time Frame: 48 weeks ]
- Incidence of mortality and/or AIDS-defining illnesses [ Time Frame: 48 weeks ]
- Change in absolute CD4+ count from baseline [ Time Frame: 48 weeks ]
- Incidence of antiretroviral drug resistance [ Time Frame: 48 weeks ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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

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
India | |
YR Gaitonde Centre for Substance Abuse-Related Research (YRGCSAR) | |
Chennai, Tamil Nadu, India, 600013 |
Principal Investigator: | Gregory M Lucas, MD,PhD | Johns Hopkins University School of Medicine, USA |
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 |