Switching Nevirapine Immediate Release( IR) Based Regimen to Nevirapine Extended Release (XR) Based Regimen in Human Immunodeficiency Virus One (HIV-1) Infected Patients
- Registration Number
- NCT00819052
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The primary objective of this study is to demonstrate the efficacy of nevirapine extended release (NVP XR) based regimen for HIV-1 infected patients who were receiving nevirapine immediate release (NVP IR) based regimen for at least 18 prior weeks of therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 445
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NVP IR Nevirapine IR 200 mg orally twice a day (po BID) NVP IR Nevirapine XR 200 mg orally twice a day (po BID) NVP XR Nevirapine XR 400 mg orally once a day (po QD)
- Primary Outcome Measures
Name Time Method Comparison of Virologic Response at Week 24 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population week 24 Primary endpoint was the number of patients with a sustained virologic response through week 24
- Secondary Outcome Measures
Name Time Method Summary of CD4 Count (Cells/Cubic Millimeter) at Baseline, Full Analysis Set Population week 0 Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 2, Observed Cases, Full Analysis Set Population baseline, week 2 Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 24, Observed Cases, Full Analysis Set Population baseline, week 24 Comparison of CD4 Count (Cells/Cubic Millimeter) Change From Baseline at Week 24, Observed Cases, Full Analysis Set Population baseline, week 24 Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population last available visit, up to 144 weeks Endpoint was the number of patients with a sustained virologic response at their last available visit
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 48, Observed Cases, Full Analysis Set Population baseline, week 48 Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 60, Observed Cases, Full Analysis Set Population baseline, week 60 Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 108, Observed Cases, Full Analysis Set Population baseline, week 108 Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 144, Observed Cases, Full Analysis Set Population baseline, week 144 Proportion of Virologic Response (Viral Load <400 Copies/mL) Trough Week 144 week 144 Endpoint was the number of patients with a sustained virologic response through week 144
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population week 24 Endpoint was the number of patients with a sustained virologic response through week 24
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 4, Observed Cases, Full Analysis Set Population baseline, week 4 Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 84, Observed Cases, Full Analysis Set Population baseline, week 84 Trough Plasma Concentration Day 1 to week 48 Trough plasma concentrations of Nevirapine at steady state after multiple oral administrations of Nevirapine treatments from day 1 (visit 2) to week 48 (visit 9).
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 96, Observed Cases, Full Analysis Set Population baseline, week 96 Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Last Available Visit, Observed Cases, Full Analysis Set Population baseline, last available visit (up to 144 weeks) Change From Baseline in VL (HIV-1 Viral Load) at Each Visit week 48, 60, 72, 84, 96, 108, 120, 132, 144, last available visit Changes in Safety Parameters Related to Treatment until week 144 Occurence of investigations related to treatment
Occurence of Rashes 144 weeks drug-related rashes by severity
Time to Loss of Virologic Response 48 weeks Kaplan-Meier Estimates of time to loss of virologic response defined as the time between the start of treatment and the time of treatment failure, up to and including the time when the last patient was on treatment for 48 weeks.
Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population week 0 to 24 Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 12, Observed Cases, Full Analysis Set Population baseline, week 12 Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 72, Observed Cases, Full Analysis Set Population baseline, week 72 Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 120, Observed Cases, Full Analysis Set Population baseline, week 120 Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 132, Observed Cases, Full Analysis Set Population baseline, week 132 Genotypic Resistance Associated With Virologic Failure 48 weeks Genotypic resistance associated with virologic failure.
This endpoint was not analysed due to lack of data.Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 8, Observed Cases, Full Analysis Set Population baseline, week 8 Occurence of Hepatic Events 144 weeks New AIDS or AIDS-related Progression Event or Death 144 weeks
Trial Locations
- Locations (39)
1100.1526.1012 Boehringer Ingelheim Investigational Site
🇺🇸Beverly Hills, California, United States
1100.1526.3306A Boehringer Ingelheim Investigational Site
🇫🇷Bobigny, France
1100.1526.3304A Boehringer Ingelheim Investigational Site
🇫🇷Nice cedex 3, France
1100.1526.4903 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
1100.1526.4911 Boehringer Ingelheim Investigational Site
🇩🇪Hamburg, Germany
1100.1526.4403 Boehringer Ingelheim Investigational Site
🇬🇧London, United Kingdom
1100.1526.3311A Boehringer Ingelheim Investigational Site
🇫🇷Bordeaux, France
1100.1526.4402 Boehringer Ingelheim Investigational Site
🇬🇧Tooting, London, United Kingdom
1100.1526.4906 Boehringer Ingelheim Investigational Site
🇩🇪Düsseldorf, Germany
1100.1526.4902 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
1100.1526.4909 Boehringer Ingelheim Investigational Site
🇩🇪Frankfurt, Germany
1100.1526.4915 Boehringer Ingelheim Investigational Site
🇩🇪München, Germany
1100.1526.3312A Boehringer Ingelheim Investigational Site
🇫🇷Le Kremlin-Bicêtre Cedex, France
1100.1526.3308A Boehringer Ingelheim Investigational Site
🇫🇷Montpellier cedex 5, France
1100.1526.4904 Boehringer Ingelheim Investigational Site
🇩🇪Bochum, Germany
1100.1526.4905 Boehringer Ingelheim Investigational Site
🇩🇪Bonn, Germany
1100.1526.4912 Boehringer Ingelheim Investigational Site
🇩🇪Hamburg, Germany
1100.1526.3301A Boehringer Ingelheim Investigational Site
🇫🇷Lyon Cedex 3, France
1100.1526.3310A Boehringer Ingelheim Investigational Site
🇫🇷Marseille cedex 9, France
1100.1526.4908 Boehringer Ingelheim Investigational Site
🇩🇪Frankfurt/Main, Germany
1100.1526.3302A Boehringer Ingelheim Investigational Site
🇫🇷Nantes, France
1100.1526.4913 Boehringer Ingelheim Investigational Site
🇩🇪Hannover, Germany
1100.1526.4907 Boehringer Ingelheim Investigational Site
🇩🇪Köln, Germany
1100.1526.4910 Boehringer Ingelheim Investigational Site
🇩🇪Hamburg, Germany
1100.1526.4914 Boehringer Ingelheim Investigational Site
🇩🇪Köln, Germany
1100.1526.4901 Boehringer Ingelheim Investigational Site
🇩🇪Freiburg, Germany
1100.1526.4405 Boehringer Ingelheim Investigational Site
🇬🇧London, United Kingdom
1100.1526.1013 Boehringer Ingelheim Investigational Site
🇺🇸Los Angeles, California, United States
1100.1526.1002 Boehringer Ingelheim Investigational Site
🇺🇸Miami, Florida, United States
1100.1526.1011 Boehringer Ingelheim Investigational Site
🇺🇸Long Beach, California, United States
1100.1526.1014 Boehringer Ingelheim Investigational Site
🇺🇸Beverly Hills, California, United States
1100.1526.1001 Boehringer Ingelheim Investigational Site
🇺🇸Washington, District of Columbia, United States
1100.1526.1005 Boehringer Ingelheim Investigational Site
🇺🇸Miami Beach, Florida, United States
1100.1526.1004 Boehringer Ingelheim Investigational Site
🇺🇸Washington, District of Columbia, United States
1100.1526.1006 Boehringer Ingelheim Investigational Site
🇺🇸Clearwater, Florida, United States
1100.1526.1003 Boehringer Ingelheim Investigational Site
🇺🇸Berkley, Michigan, United States
1100.1526.1007 Boehringer Ingelheim Investigational Site
🇺🇸Austin, Texas, United States
1100.1526.3307A Boehringer Ingelheim Investigational Site
🇫🇷La Roche sur Yon, France
1100.1526.4404 Boehringer Ingelheim Investigational Site
🇬🇧Manchester, United Kingdom