Dual Boosted - Protease Inhibitor (PI) Pharmacokinetics (PK) Trial (Tipranavir / Ritonavir) in Highly Treatment-experienced HIV-1 Infected Patients
- Conditions
- HIV Infections
- Registration Number
- NCT00056641
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This is an open-label, randomized, parallel group pharmacokinetics trial of tipranavir/ritonavir (TPV/RTV), alone or in combination with RTV-boosted saquinavir (SQV), amprenavir (APV) or lopinavir (LPV), plus an optimized background regimen, in multiple antiretroviral (ARV) experienced HIV-1 patients.
The primary objective is to determine the safety and pharmacokinetics of:
TPV/RTV given with an optimized background regimen (OBR) and TPV/RTV given in combination with saquinavir, amprenavir, or Kaletra® and an optimized background regimen (OBR).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 328
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change of the 2nd Protease Inhibitor (PI) (APV, LPV. SQV) mean concentration (C12h) Day 14 to Day 28 Occurrence of adverse events; Proportion of patients with laboratory abnormalities; Proportion of patients with SAEs week 4
- Secondary Outcome Measures
Name Time Method Mean concentration (C12h) of TPV (TPV/r group); Mean concentration (C12h) of RTV (TPV/r group) Week 1 and 2 Assessment of patient adherence Week 1 to 4 Mean concentration (C12h) of TPV (PI/TPV/r group); Mean concentration (C12h) of RTV (PI/TPV/r group) Week 3 and 4 Change in AUC(0-12h) of RTV from week 2; Change in Cmax of RTV from week 2; Change in C12h of RTV from week 2 week 4 AUC(0-12h) of RTV; Cmax of RTV; C12h of RTV week 2 and 4 Change in AUC(0-12h) of TPV from week 2; Change in Cmax of TPV from week 2; Change in C12h of TPV from week 2 week 4 Area under the Curve (AUC(0-12h)) of the 2nd PI (APV, LPV. SQV); Maximum concentration (Cmax) of the 2nd PI (APV, LPV. SQV); Concentration (C12h) of the 2nd PI (APV, LPV. SQV) week 2 and 4 Change in viral load; Proportion of virologic responders week 2, 4, 8, 16 and 24
Trial Locations
- Locations (81)
Boehringer Ingelheim Investigational Site
🇩🇪Stuttgart, Germany
Kaiser Permanente Medical Center
🇺🇸San Francisco, California, United States
San Francisco VAMC
🇺🇸San Francisco, California, United States
Washington DC VA Medical Center
🇺🇸Washington, District of Columbia, United States
North Broward Hospital District
🇺🇸Fort Lauderdale, Florida, United States
Mercer University School of Medicine
🇺🇸Macon, Georgia, United States
University of Kentucky Medical Center
🇺🇸Lexington, Kentucky, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Albany Medical College
🇺🇸Albany, New York, United States
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