Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001122
Status:
COMPLETED
Last Update Posted:
2011-03-02
First Post:
1999-11-02
Brief Title:
A Study of an Adherence Plan to Help HIV-Positive Patients Take Their First Anti-HIV Medications Correctly
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase II Randomized Open-Label Study of Maximally Assisted Therapy MAT Compared to Self-Administered Therapy SAT for the Treatment of HIV Infection in Antiretroviral Naive Subjects With CD4 Greater Than or Equal to 200 Cellsmm3
Status:
COMPLETED
Status Verified Date:
2005-01
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 purpose of this study is to see if observed therapy can help HIV-positive patients stick to their anti-HIV medication schedule Observed therapy means that a nurse will watch patients take their medications to make sure that they take them correctly
It is very important that HIV-positive patients take their anti-HIV medications correctly so they get the best possible benefit from them Taking the drugs correctly called adherence may keep HIV virus levels in the blood viral load low for a longer time Adherence can also slow the development of drug resistance and this is especially important in patients with early HIV infection who are just beginning treatment However anti-HIV medication schedules are often complicated and many patients have difficulty remembering to take their drugs at the correct time This study will look at the effectiveness of a plan to help patients with this problem
It is very important that HIV-positive patients take their anti-HIV medications correctly so they get the best possible benefit from them Taking the drugs correctly called adherence may keep HIV virus levels in the blood viral load low for a longer time Adherence can also slow the development of drug resistance and this is especially important in patients with early HIV infection who are just beginning treatment However anti-HIV medication schedules are often complicated and many patients have difficulty remembering to take their drugs at the correct time This study will look at the effectiveness of a plan to help patients with this problem
Detailed Description:
Novel approaches are needed to improve adherence to combination antiretroviral therapy Nonadherence can lead to reduced drug levels and inadequate viral suppression which accelerates drug resistance Thus nonadherence in the first few months of primary HIV infection can limit therapeutic options for an individual years later Barriers to optimal treatment adherence in patients with early HIV infection include complex treatment regimens which disrupt daily routines drug intolerance and concomitant illness including depression Directly observed therapy has been successful in improving overall effectiveness of antituberculosis therapy and may be a useful strategy in HIV-infected patients
All patients receive combination antiretroviral therapy with didanosine ddI stavudine d4T efavirenz EFV and nelfinavir NFV Patients are randomized to self-administered SAT versus observed MAT therapy for 24 weeks Patients randomized to MAT receive one directly observed dose ddI d4T EFV and NFV of their antiretroviral regimen by a field worker or nurse at the clinic 5 days per week As a reminder for the second NFV and d4T dose MAT patients are provided with an alarm watch programmed to sound at dosing times The alarm watch also serves as a reminder for weekend doses that will not be directly observed Patients randomized to SAT receive standard care All patients are monitored with monthly plasma HIV RNA levels and CD4 and CD8 cell counts At Week 24 all patients are crossed over to SAT for an additional 48 weeks of follow-up
All patients receive combination antiretroviral therapy with didanosine ddI stavudine d4T efavirenz EFV and nelfinavir NFV Patients are randomized to self-administered SAT versus observed MAT therapy for 24 weeks Patients randomized to MAT receive one directly observed dose ddI d4T EFV and NFV of their antiretroviral regimen by a field worker or nurse at the clinic 5 days per week As a reminder for the second NFV and d4T dose MAT patients are provided with an alarm watch programmed to sound at dosing times The alarm watch also serves as a reminder for weekend doses that will not be directly observed Patients randomized to SAT receive standard care All patients are monitored with monthly plasma HIV RNA levels and CD4 and CD8 cell counts At Week 24 all patients are crossed over to SAT for an additional 48 weeks of follow-up
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AEHIV 003 MAT | None | None | None |