HIV InfectionsPhase 2/3DAART+NCT00709007
Directly Administered Antiretroviral Therapy (DAART) Among HIV-1infected Injecting Drug Users (IDUs) in Chennai, India
A Phase 2/3 study testing Directly Administered Antiretroviral Therapy (DAART) and SAT in people with HIV Infections and Heroin Dependence, run by Johns Hopkins University at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Heroin Dependence
- What is being tested?
- Directly Administered Antiretroviral Therapy (DAART) and SAT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2008to Jul 2011
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
YR Gaitonde Centre for Substance Abuse-Related Research (YRGCSAR)
Chennai, Tamil Nadu, 600013
About this 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
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.
- Conditions
- HIV Infections, Heroin Dependence
- Being tested
- Directly Administered Antiretroviral Therapy (DAART), SAT
- Medical subject headings
- HIV Infections, Heroin Dependence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Directly Administered Antiretroviral Therapy (DAART)Behavioural
Participants are observed taking HIV medications by study staff on days when they receive opioid agonist therapy (sub-lingual buprenorphine) at the clinic.
SATBehavioural
Participants take their HIV medications by themselves.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Directly Administered Antiretroviral Therapy (DAART) |
| SAT | Active comparator | Participants take their HIV medications on their own but visit the clinic for opioid agonist substitution therapy. Receives: Behavioral: SAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV RNA < 400 copies/ml
Measured: 48 weeks
Secondary outcomes (3)
Incidence of mortality and/or AIDS-defining illnesses
Measured: 48 weeks
Change in absolute CD4+ count from baseline
Measured: 48 weeks
Incidence of antiretroviral drug resistance
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionJul 2010 (estimated)
- Study completionJul 2011 (estimated)
Why it stopped: No participants satisfied eligibility criteria and were enrolled into the study since July 2008.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Investigators
- Gregory M Lucas, MD,PhD, Principal investigator, Johns Hopkins University School of Medicine, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00709007
- Sponsor's protocol ID
- R01DA018577-03S1
- Acronym
- DAART+
- Status last verified
- Mar 2009
- First submitted
- 1 Jul 2008
- Last updated
- 15 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00709007
- Acronym / sponsor ID
- DAART+ / R01DA018577-03S1
- Conditions
- HIV Infections, Heroin Dependence
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants satisfied eligibility criteria and were enrolled into the study since July 2008.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jul 2008
- Primary completion
- Jul 2010 (estimated)
- Study completion
- Jul 2011 (estimated)
- First posted
- 3 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DAART | Experimental | 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 | Behavioral: SATParticipants take their HIV medications on their own but visit the clinic for opioid agonist substitution therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | DAART |
| SATParticipants take their HIV medications by themselves. | Behavioural | SAT |
Primary outcome
HIV RNA < 400 copies/ml
Time frame: 48 weeks
3 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory M Lucas, MD,PhD principal investigator
Johns Hopkins University School of Medicine, USA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Directly Administered Antiretroviral Therapy (DAART) and SAT in people with HIV Infections and Heroin Dependence, run by Johns Hopkins University at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV RNA < 400 copies/ml (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2015.