Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00196612
Status:
COMPLETED
Last Update Posted:
2005-09-20
First Post:
2005-09-12
Brief Title:
Once Daily Antiretroviral Therapy in HIV Infected Adults Treated With HAART
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Organization:
French National Agency for Research on AIDS and Viral Hepatitis
Study Overview
Official Title:
Phase II Randomized Trial Comparing Efficacy and Safety of the Maintenance of a HAART Association Protease Inhibitor Containing Versus a Once Daily Antiretroviral Triple Association in HIV Adult Patients With Undetectable Viral LoadANRS 099 ALIZE
Status:
COMPLETED
Status Verified Date:
2005-09
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 combination of two nucleoside analogues and one protease inhibitor is a highly active antiretroviral therapy HAART in HIV infected adults In those with an undetectable viral load a once daily combination of FTC ddI efavirenz would be easier to take with less side effects and the same efficacy The aim of the study was to evaluate if the once daily combination presents the same efficacy than the HAART therapy with less side effects and a better adherence
Detailed Description:
The combination of two nucleoside analogues and one protease inhibitor is a highly active antiretroviral therapy HAART in HIV infected adults but side effects an the great number of pills induces less adherence to the therapy Once daily combination with a lower number of pills could be more easy to take with a greater adherence less side effects and the same efficacy 355 patients are recruited in the study randomized in two treatment groups maintenance of the HAART therapy versus changing for a once daily combination of FTC ddI efavirenz during 48 weeks The primary end-point is the viral success maintained until 48 weeks Secondary end-point is the safety and adherence
The trial is prolonged for a total of 48 weeks
The trial is prolonged for a total of 48 weeks
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