Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00367172
Status:
COMPLETED
Last Update Posted:
2020-03-31
First Post:
2006-08-21
Brief Title:
Directly Observed Antiretroviral Therapy Among Active Drug Users
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Directly Observed Antiretroviral Therapy Among Active Drug Users
Status:
COMPLETED
Status Verified Date:
2009-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DA013805 | NIH | None | httpsreporternihgovquickSearchR01DA013805 |