Evaluation of safety and efficacy of Tipranavir (TPV) boosted with Ritonavir (RTV) versus an active control arm (Lopinavir / RTV) in antiretroviral (ARV) therapy naïve HIV-1 infected patients
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
562
Boehringer Ingelheim Investigational Site
BsAs, Argentina
Fundacion Huesped
Buenos Aires, Argentina
Hospital de Agudos Teodoro Alvarez
Buenos Aires, Argentina
Hospital Posadas
Haedo, Argentina
Boehringer Ingelheim Investigational Site
Darlinghurst, New South Wales, Australia
St Vincents Hospital;
The primary endpoint is the proportion of treatment responders at 48 weeks. A treatment responder is a patient with a viral load (VL) less than 50 copies/mL measured at two consecutive visits without prior rebound or change of ARV therapy.
Further analyses to evaluate the primary endpoint at 24, 96, and 156 weeks. Secondary endpoints include proportion of patients with VL< 400 copies/mL, change from baseline in CD4+ cell counts at each visit, time to a new CDC class C progression event.
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Darlinghurst, New South Wales, Australia
Boehringer Ingelheim Investigational Site
Liverpool, New South Wales, Australia
Boehringer Ingelheim Investigational Site
Surry Hills, New South Wales, Australia
Boehringer Ingelheim Investigational Site
Carlton, Victoria, Australia
Alfred Hospital
Melbourne, Victoria, Australia
...and 71 more locations