Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00196599
Status:
COMPLETED
Last Update Posted:
2005-09-20
First Post:
2005-09-12
Brief Title:
Pilot Study on Once Daily FTC ddI Efavirenz Combination in Antiretroviral Naive HIV Infected Adults
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:
Pilot Study on Efficacy and Safety of a Once Daily FTC ddI Efavirenz Combination in Antiretroviral Naive HIV Infected Adults ANRS 091 MONTANA
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:
In 1999 when initiating antiretroviral treatment in HIV infected adults a triple combination with protease inhibitor is recommended Such therapy induces side effects and the number of pills may reduce therapy adherence The aim of this study is to evaluate the efficacy and the safety of a once daily FTC ddI efavirenz combination in HIV patients with CD4 cell count over 100mm3 antiretroviral naive
Detailed Description:
In 1999 when initiating antiretroviral treatment in HIV infected adults a triple combination with protease inhibitor is recommended Side effects of this products and the number of pills may induce a lower adherence and thus a lower efficacy 40 patients with a CD4 count over 100mm3 a HIV RNA over 5000 copiesml and antiretroviral naive take the once daily combination of FTC ddI efavirenz during 24 weeks The primary end-point is the viral success maintained from 12 weeks until 24 weeks Secondary end-point is the adherence to the association and safety
The trial is prolonged during a total of 72 weeks
The trial is prolonged during a total of 72 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