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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
328
Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
Boehringer Ingelheim Investigational Site
Berkeley, California, United States
Boehringer Ingelheim Investigational Site
Fountain Valley, California, United States
Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
Boehringer Ingelheim Investigational Site
San Francisco, California, United States
Change of the 2nd Protease Inhibitor (PI) (APV, LPV. SQV) mean concentration (C12h)
Time frame: Day 14 to Day 28
Occurrence of adverse events; Proportion of patients with laboratory abnormalities; Proportion of patients with SAEs
Time frame: week 4
Mean concentration (C12h) of TPV (TPV/r group); Mean concentration (C12h) of RTV (TPV/r group)
Time frame: Week 1 and 2
Mean concentration (C12h) of TPV (PI/TPV/r group); Mean concentration (C12h) of RTV (PI/TPV/r group)
Time frame: Week 3 and 4
Assessment of patient adherence
Time frame: Week 1 to 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)
Time frame: 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
Time frame: week 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
Time frame: week 4
AUC(0-12h) of RTV; Cmax of RTV; C12h of RTV
Time frame: week 2 and 4
Change in viral load; Proportion of virologic responders
Time frame: week 2, 4, 8, 16 and 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Kaiser Permanente Medical Center
San Francisco, California, United States
San Francisco VAMC
San Francisco, California, United States
Boehringer Ingelheim Investigational Site
Norwalk, Connecticut, United States
Washington DC VA Medical Center
Washington D.C., District of Columbia, United States
North Broward Hospital District
Fort Lauderdale, Florida, United States
...and 99 more locations