Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00199979
Status:
UNKNOWN
Last Update Posted:
2005-12-16
First Post:
2005-09-12
Brief Title:
Zidovudine Lamivudine Nevirapine Twice Daily Versus Tenofovir Lamivudine Nevirapine Once Daily in ARV-Naive Patients
Sponsor:
MEDEX
Organization:
MEDEX
Study Overview
Official Title:
Multicenter Randomized Open-Label Trial Assessing the Efficacy of Zidovudine Lamivudine and Nevirapine Combination Administered Twice Daily Versus the Association of Tenofovir Lamivudine and Nevirapine Once Daily in Antiretroviral Naive HIV-1 Infected Patients
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
RECRUITING
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 study will compare the immuno-virological efficacy and safety of a once daily antiretroviral combination tenofovir lamivudine nevirapine versus a twice daily association fixed dose combination of zidovudinelamivudine nevirapine in ARV-Naive HIV-1 infected subjects with CD4 cell count below 350µL or below 15 whatever the viral load Pharmacological nevirapine concentrations and virologic data resistance mutations in case of failure will also be provided as well as adherence rate and quality of life in respect of the treatment arms
Detailed Description:
96-week antiviral efficacy of tenofovir lamivudine nevirapine once daily versus a reference antiretroviral treatment given twice daily zidovudinelamivudine nevirapine
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