HIV/AIDSNCT00367172
Directly Observed Antiretroviral Therapy Among Active Drug Users
A study testing Directly Administered Antiretroviral Therapy in people with HIV/AIDS and Substance Abuse, run by Yale University at 1 site in United States.
Trial summary
The goal of this randomized, controlled trial is to compare the effectiveness of a community-based program of providing supervised antiretroviral therapy to HIV-positive drug users, compared to having the patients take the medicines on their own. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV/AIDS, Substance Abuse
- What is being tested?
- Directly Administered Antiretroviral Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2001to Dec 2006
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- being HIV seropositive;
- being eligible for and/or being prescribed HAART
- living within the city of New Haven
- actively using heroin and/or cocaine in the previous six months
- receiving no more than a twice-daily regimen
Who cannot join
- Not meeting inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine
New Haven, Connecticut, 06510
About this study
The goal of this randomized, controlled trial is to compare the effectiveness of a community-based program of providing supervised antiretroviral therapy to HIV-positive drug users, compared to having the patients take the medicines on their own.
Read the detailed description
Highly active antiretroviral therapy (HAART) has dramatically reduced morbidity and mortality from HIV disease, but these benefits have not been conferred equally among all patient populations. Injection drug users (IDUs) have shown particularly less favorable outcomes, with HIV progression remaining at high levels, and IDU remains a significant risk behavior for the spread of HIV worldwide, with explosive epidemics in Eastern Europe, Russia, and Southeast Asia. It is therefore essential to develop and test strategies of HIV treatment that optimize outcomes for this population, in order to reduce morbidity and mortality and to curb secondary transmission.
Directly observed therapy (DOT) for tuberculosis has resulted in impressive improvements in adherence and clinical response and marked reductions in the development of resistance. The time-limited treatment of tuberculosis, the inherently different transmission patterns of tuberculosis and HIV, and the complexity of antiretroviral therapy have raised concerns about translating the DOT model to HIV. Successful, but non-comparative demonstration programs of directly administered antiretroviral therapy (DAART) have been implemented in methadone maintenance programs, community-based settings, skilled nursing facilities, and in prisons. None of these, however, have targeted active drug users or used a prospective, randomized controlled trial (RCT) design to rigorously determine the efficacy of DAART as an intervention to improve HIV outcomes among active drug users. One RCT of DAART recently failed to demonstrate an impact on virological outcomes among low-income HIV+ patients, but these results are unlikely to be applicable to IDUs or other populations with demonstrated problematic adherence.
We therefore conducted the first randomized controlled trial to address this question, consisting of six months of DAART versus self-administered therapy (SAT) among active drug users in a community setting. The objective was to determine the potential efficacy of a six-month DAART program on HIV infection, using surrogate markers of HIV- RNA levels and CD4+ T lymphocyte counts.
- Conditions
- HIV/AIDS, Substance Abuse
- Being tested
- Directly Administered Antiretroviral Therapy
- Keywords
- human immunodeficiency virus, acquired immunodeficiency syndrome, substance abuse, directly administered antiretroviral therapy, adherence, directly observed therapy
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Substance-Related Disorders, Directly Observed Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Directly Administered Antiretroviral TherapyBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Virological Success, defined as greater than 1 Log HIV-1 Copies/mL reduction or Viral Load Less than 400 copies/mL at the end of six months on the intervention.
Secondary outcomes (5)
Mean change in HIV-1 viral load from baseline to six months at the end of the intervention.
Virological Success at six months following the termination of the intervention.
3-Day Recall measures of adherence at the end of six months on the intervention.
Mean change in HIV-1 viral load from baseline six months following the termination of the intervention.
Mean change in CD4+ T cells from baseline to the end of six months on the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2006 (estimated)
- Study startJun 2001
- Primary completionJun 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Yale 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Investigators
- Frederick L Altice, M.D., Principal investigator, Yale UniversityGerald H Friedland, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00367172
- Sponsor's protocol ID
- 0003011701
- Other IDs
- R01DA013805
- Status last verified
- Aug 2009
- First submitted
- 21 Aug 2006
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Altice FL, Mezger JA, Hodges J, Bruce RD, Marinovich A, Walton M, Springer SA, Friedland GH. Developing a directly administered antiretroviral therapy intervention for HIV-infected drug users: implications for program replication. Clin Infect Dis. 2004 Jun 1;38 Suppl 5:S376-87. doi: 10.1086/421400.
PubMed 15156426Altice FL, Maru DS, Bruce RD, Springer SA, Friedland GH. Superiority of directly administered antiretroviral therapy over self-administered therapy among HIV-infected drug users: a prospective, randomized, controlled trial. Clin Infect Dis. 2007 Sep 15;45(6):770-8. doi: 10.1086/521166. Epub 2007 Aug 13.
PubMed 17712763
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Directly Observed Antiretroviral Therapy Among Active Drug Users
- ClinicalTrials.gov ID
- NCT00367172
- Acronym / sponsor ID
- 0003011701
- Conditions
- HIV/AIDS, Substance Abuse
- Keywords
- human immunodeficiency virus, acquired immunodeficiency syndrome, substance abuse, directly administered antiretroviral therapy, adherence, directly observed therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Jun 2001
- Primary completion
- Jun 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 22 Aug 2006 (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.
The goal of this randomized, controlled trial is to compare the effectiveness of a community-based program of providing supervised antiretroviral therapy to HIV-positive drug users, compared to having the patients take the medicines on their own.
Detailed description
Highly active antiretroviral therapy (HAART) has dramatically reduced morbidity and mortality from HIV disease, but these benefits have not been conferred equally among all patient populations. Injection drug users (IDUs) have shown particularly less favorable outcomes, with HIV progression remaining at high levels, and IDU remains a significant risk behavior for the spread of HIV worldwide, with explosive epidemics in Eastern Europe, Russia, and Southeast Asia. It is therefore essential to develop and test strategies of HIV treatment that optimize outcomes for this population, in order to reduce morbidity and mortality and to curb secondary transmission.
Directly observed therapy (DOT) for tuberculosis has resulted in impressive improvements in adherence and clinical response and marked reductions in the development of resistance. The time-limited treatment of tuberculosis, the inherently different transmission patterns of tuberculosis and HIV, and the complexity of antiretroviral therapy have raised concerns about translating the DOT model to HIV. Successful, but non-comparative demonstration programs of directly administered antiretroviral therapy (DAART) have been implemented in methadone maintenance programs, community-based settings, skilled nursing facilities, and in prisons. None of these, however, have targeted active drug users or used a prospective, randomized controlled trial (RCT) design to rigorously determine the efficacy of DAART as an intervention to improve HIV outcomes among active drug users. One RCT of DAART recently failed to demonstrate an impact on virological outcomes among low-income HIV+ patients, but these results are unlikely to be applicable to IDUs or other populations with demonstrated problematic adherence.
We therefore conducted the first randomized controlled trial to address this question, consisting of six months of DAART versus self-administered therapy (SAT) among active drug users in a community setting. The objective was to determine the potential efficacy of a six-month DAART program on HIV infection, using surrogate markers of HIV- RNA levels and CD4+ T lymphocyte counts.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- being HIV seropositive;
- being eligible for and/or being prescribed HAART
- living within the city of New Haven
- actively using heroin and/or cocaine in the previous six months
- receiving no more than a twice-daily regimen
Key exclusion criteria (1 listed)
- Not meeting inclusion criteria
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 | Behavioural | – |
Primary outcome
Virological Success, defined as greater than 1 Log HIV-1 Copies/mL reduction or Viral Load Less than 400 copies/mL at the end of six months on the intervention.
5 secondary outcomes
Mean change in HIV-1 viral load from baseline to six months at the end of the intervention.
Virological Success at six months following the termination of the intervention.
3-Day Recall measures of adherence at the end of six months on the intervention.
Mean change in HIV-1 viral load from baseline six months following the termination of the intervention.
Mean change in CD4+ T cells from baseline to the end of six months on the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Background: PubMed 15156426Altice FL, Mezger JA, Hodges J, Bruce RD, Marinovich A, Walton M, Springer SA, Friedland GH. Developing a directly administered antiretroviral therapy intervention for HIV-infected drug users: implications for program replication. Clin Infect Dis. 2004 Jun 1;38 Suppl 5:S376-87. doi: 10.1086/421400.
- Derived from this study: PubMed 17712763Altice FL, Maru DS, Bruce RD, Springer SA, Friedland GH. Superiority of directly administered antiretroviral therapy over self-administered therapy among HIV-infected drug users: a prospective, randomized, controlled trial. Clin Infect Dis. 2007 Sep 15;45(6):770-8. doi: 10.1086/521166. Epub 2007 Aug 13.
Related trials for HIV/AIDS
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Frederick L Altice, M.D. principal investigator
Yale University
Gerald H Friedland principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Directly Administered Antiretroviral Therapy in people with HIV/AIDS and Substance Abuse, run by Yale University at 1 site in United States.
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 5 inclusion and 1 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: finished, as of the sponsor's last update on 31 Mar 2020. 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 United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Virological Success, defined as greater than 1 Log HIV-1 Copies/mL reduction or Viral Load Less than 400 copies/mL at the end of six months on the intervention.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00367172, which also lists 2 linked publications.
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 31 Mar 2020.