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

This study has been withdrawn prior to enrollment.

(No participants satisfied eligibility criteria and were enrolled into the study since July 2008.)

Sponsor:

Collaborator:

National Institute on Drug Abuse (NIDA)

Information provided by:

Johns Hopkins University

ClinicalTrials.gov Identifier:

NCT00709007

First received: July 1, 2008

Last updated: April 14, 2015

Last verified: March 2009

History of Changes

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 2 Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Heroin

U.S. FDA Resources

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 ]


Enrollment:	0
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
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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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


Responsible Party:	Gregory M Lucas, Johns Hopkins University School of Medicine
ClinicalTrials.gov Identifier:	NCT00709007 History of Changes
Other Study ID Numbers:	R01DA018577-03S1
Study First Received:	July 1, 2008
Last Updated:	April 14, 2015
Health Authority:	India: Indian Council of Medical Research India: Institutional Review Board United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 23, 2016

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