Pharmacokinetics and Safety Study of Tipranavir in Combination With Low Dose Ritonavir in Human Immunodeficiency Virus (HIV)-Infected Children
- Registration Number
- NCT00076999
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The primary objective of this study is to assess the safety and tolerability of tipranavir (TPV) oral formulation and soft gelatin capsules together with low-dose ritonavir in HIV-infected children and adolescents, to provide information concerning the pharmacokinetic characteristics of tipranavir and ritonavir in this age group, and to determine the relative bioavailability of the TPV liquid formulation and TPV capsule formulation in adolescents switching from liquid to capsule.
The secondary objective of this study is the determination of the dose of topranavir and ritonavir (TPV/r) in children and adolescents between 2 and 18 years of age required for an adult equivalent systemic exposure of TPV/r 500 mg / 200 mg.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 115
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TPV/r 290/115 mg/m^2 TPV oral solution TPV and RTV oral solution low dose TPV/r 290/115 mg/m^2 RTV oral solution TPV and RTV oral solution low dose TPV/r 375/150 mg/m^2 TPV oral solution TPV and RTV oral solution high dose TPV/r 375/150 mg/m^2 RTV oral solution TPV and RTV oral solution high dose
- Primary Outcome Measures
Name Time Method Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation up to 288 weeks Intensity of adverse events were graded by the investigator based on the DAIDS standardized table (Division of AIDS, National Institute of Health). DAIDS Grade 3 (Severe) and Grade 4 (Life Threatening) were identified.
Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation up to 288 weeks Intensity of adverse events were graded by the investigator based on the DAIDS standardized table (Division of AIDS, National Institute of Health). DAIDS Grade 3 (Severe) and Grade 4 (Life Threatening) were identified.
- Secondary Outcome Measures
Name Time Method Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 24 (Non-completers Considered Failures) baseline, week 24 Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 48 (Non-completers Considered Failures) baseline, week 48 Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 100 (Non-completers Considered Failures) baseline, week 100 Number Patients With HIV RNA <400 Copies/mL at Week 24 (Non-completers Considered Failures) baseline, week 24 Number Patients With HIV RNA <400 Copies/mL at Week 48 (Non-completers Considered Failures) baseline, week 48 Number Patients With HIV RNA <400 Copies/mL at Week 100 (Non-completers Considered Failures) baseline, week 100 Median Change From Baseline in Viral Load log10 Copies/mL at Week 48 (Last Observation Carried Forward) baseline, week 48 Median Change From Baseline in Viral Load log10 Copies/mL at Week 100 (Last Observation Carried Forward) baseline, week 100 Baseline Median CD4+ Cell Count (Cells/mm3) baseline Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 24 (Last Observation Carried Forward) baseline, week 24 Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 48 (Last Observation Carried Forward) baseline, week 48 Number Patients With HIV RNA <50 Copies/mL at Week 24 (Non-completers Considered Failures) baseline, week 24 Number Patients With HIV RNA <50 Copies/mL at Week 48 (Non-completers Considered Failures) baseline, week 48 Number Patients With HIV RNA <50 Copies/mL at Week 100 (Non-completers Considered Failures) baseline, week 100 Baseline Median Viral Load log10 Copies/mL baseline Median Change From Baseline in Viral Load log10 Copies/mL at Week 24 (Last Observation Carried Forward) baseline, week 24 Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 100 (Last Observation Carried Forward) baseline, week 100 Median Baseline CD4 Percent baseline Percentage of lymphocytes that are CD4 cells
Median Change From Baseline in CD4 Percent at Week 24 (Last Observation Carried Forward) baseline, week 24 Percentage of lymphocytes that are CD4 cells
Median Change From Baseline in CD4 Percent at Week 48 (Last Observation Carried Forward) baseline, week 48 Percentage of lymphocytes that are CD4 cells
Median Change From Baseline in CD4 Percent at Week 100 (Last Observation Carried Forward) baseline, week 100 Percentage of lymphocytes that are CD4 cells
Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 8 week 8 Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 16 week 16 Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 24 week 24 Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 48 week 48
Trial Locations
- Locations (30)
1182.14.11002 Boehringer Ingelheim Investigational Site
🇨🇦Toronto, Ontario, Canada
1182.14.00003 Boehringer Ingelheim Investigational Site
🇺🇸Houston, Texas, United States
1182.14.00010 Boehringer Ingelheim Investigational Site
🇺🇸Hartford, Connecticut, United States
1182.14.5401 Fundación Huésped
🇦🇷Capital Federal, Argentina
1182.14.00007 Boehringer Ingelheim Investigational Site
🇺🇸Memphis, Tennessee, United States
1182.14.55003
🇧🇷São Paulo, Brazil
1182.14.00006 Boehringer Ingelheim Investigational Site
🇺🇸Los Angeles, California, United States
1182.14.34001 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1182.14.49001 Boehringer Ingelheim Investigational Site
🇩🇪Frankfurt/Main, Germany
1182.14.00001 Boehringer Ingelheim Investigational Site
🇺🇸Los Angeles, California, United States
1182.14.00004 Boehringer Ingelheim Investigational Site
🇺🇸Chicago, Illinois, United States
1182.14.00002 Boehringer Ingelheim Investigational Site
🇺🇸Cleveland, Ohio, United States
1182.14.34002 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1182.14.11001 Boehringer Ingelheim Investigational Site
🇨🇦Montreal, Quebec, Canada
1182.14.33004 Boehringer Ingelheim Investigational Site
🇫🇷Lyon cedex 3, France
1182.14.33006 Boehringer Ingelheim Investigational Site
🇫🇷Paris cedex 12, France
1182.14.33003 Boehringer Ingelheim Investigational Site
🇫🇷Paris cedex 14, France
1182.14.00008 Boehringer Ingelheim Investigational Site
🇺🇸North Worcester, Massachusetts, United States
1182.14.00009 Boehringer Ingelheim Investigational Site
🇺🇸Springfield, Massachusetts, United States
1182.14.55002
🇧🇷São Paulo, Brazil
1182.14.49002 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
1182.14.33005 Boehringer Ingelheim Investigational Site
🇫🇷Nantes cedex 1, France
1182.14.39001 Boehringer Ingelheim Investigational Site
🇮🇹Padova, Italy
1182.14.33001 Boehringer Ingelheim Investigational Site
🇫🇷Paris cedex 15, France
1182.14.49004 Boehringer Ingelheim Investigational Site
🇩🇪München, Germany
1182.14.33002 Boehringer Ingelheim Investigational Site
🇫🇷Paris, France
1182.14.39003 Boehringer Ingelheim Investigational Site
🇮🇹Roma, Italy
1182.14.52001 CLINDI (ClÃnica de Inmunodeficiencias)
🇲🇽México, D.F., Mexico
1182.14.52002
🇲🇽México, D.F., Mexico
1182.14.00005 Boehringer Ingelheim Investigational Site
🇵🇷San Juan, Puerto Rico