The purpose of this study is to identify an optimal dose combination(s) of tipranavir (TPV) and ritonavir (RTV) for antiretroviral treatment naïve HIV-1 infected patients that can be used in pivotal trial by assessing the steady-state pharmacokinetics and short-term efficacy and safety
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Enrollment
85
1182.107.49002 Boehringer Ingelheim Investigational Site
Berlin, Germany
1182.107.49004 Boehringer Ingelheim Investigational Site
Berlin, Germany
1182.107.49003 Boehringer Ingelheim Investigational Site
Frankfurt am Main, Germany
Viral Load (log10 Copies/mL) Change From Baseline (Last Observation Carried Forward (LOCF))
Time frame: Baseline (Day 0) to Final (Day 14)
Apparent Oral Clearance I(Cl/F) of Tipranavir
Tipranavir pharmacokinetics - Clearance (CL) is defined as the dose of a drug divided by the area-under-the-concentration-time curve (AUC), ie. CL = Dose / AUC. For extravascu-lar models the fraction of dose absorbed cannot be estimated, therefore "clear-ance" for these models is actually Cl/F where F is the fraction of the drug dose which is absorbed.
Time frame: Final (Day 14)
Area Under the Curve(AUC) of Tipranavir 24 h for Once Daily (QD) and AUC 12 h for Twice Daily (BID)
Tipranavir (TPV) pharmacokinetics
Time frame: Final (Day 13 for QD, Day 14 for BID)
Concentration-24 Hour (hr) Post Dose of Tipranavir - (Cp 24 h for QD and 12 hr Post Dose (CP 12h) for BID
TPV pharmacokinetics
Time frame: Final (Day 13 for QD, Day 14 for BID)
Trough Concentration (Cmin) of Tipranavir
TPV pharmacokinetics
Time frame: Final (Day 13 for QD, Day 14 for BID)
Maximum Concentration (Cmax) of Tipranavir
TPV pharmacokinetics
Time frame: Final (Day 13 for QD, Day 14 for BID)
Volume of Distribution (V/F) of Tipranavir
Tipranavir pharmacokinetics
Time frame: Final (Day 14)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
1182.107.49001 Boehringer Ingelheim Investigational Site
München, Germany
1182.107.39001 Boehringer Ingelheim Investigational Site
Antella (fi), Italy
1182.107.39009 Boehringer Ingelheim Investigational Site
Bari, Italy
1182.107.39007 Boehringer Ingelheim Investigational Site
Ferrara, Italy
1182.107.39011 Boehringer Ingelheim Investigational Site
Palermo, Italy
1182.107.34001 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1182.107.34002 Boehringer Ingelheim Investigational Site
Barcelona, Spain
...and 2 more locations
Terminal Half-Life (t1/2) of Tipranavir
Tipranavir pharmacokinetics
Time frame: Final (Day 14)
Time to Cmax (Tmax) of Tipranavir
Tipranavir pharmacokinetics
Time frame: Final (Day 14)
AUC 24 of Ritonavir for QD and AUC 12 of Ritonavir for BID
Ritonavir pharmacokinetics
Time frame: Final (Day 13 for QD, Day 14 for BID)
Cp 24 h of Ritonavir for QD and CP 12 h of Ritonavir for BID
Ritonavir pharmacokinetics
Time frame: Final (Day 13 for QD, Day 14 for BID)
Apparent Oral Clearance I(Cl/F) of Ritonavir
Ritonavir pharmacokinetics
Time frame: Final (Day 13 for QD, Day 14 for BID)
Volume of Distribution (V/F) of Ritonavir
Ritonavir pharmacokinetics
Time frame: Final (Day 14)
Terminal Half-Life (t1/2) of Ritonavir
Ritonavir pharmacokinetics
Time frame: Final (Day 14)
Tmax of Ritonavir
Ritonavir pharmacokinetics
Time frame: Final (Day 14)
Cmax of Ritonavir
Ritonavir pharmacokinetics
Time frame: Visits baseline, 5, 7, 9 and 13 or 14
Clinical Abnormal Findings in Laboratory and Physical Examination
Time frame: Screening through the end of the study (14 days)