GRACE: A Study to Compare the Effectiveness, Safety and Tolerability of PREZISTA (Darunavir)/Ritonavir by Gender and Race When Administered With Other Antiretroviral Medications in Human Immunodeficiency Virus (HIV) Positive Women and Men.
Completed
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
Phase 3
2006-11-01
The purpose of this study is to evaluate any differences in the effectiveness, safety, and
tolerability of PREZISTA (darunavir; DRV) 600 mg, administered with ritonavir (RTV) 100 mg
twice a day on virologic response (defined as a viral load (VL) of < 50 copies/mL) over a
48-week treatment period in HIV-positive women and men. Additional antiretroviral (ARV)
agents will also be administered and will be chosen by the Investigator based on resistance
testing and prior treatment history (referred to as the Optimized Background Regimen (OBR)).
GRACE: A Study to Compare the Effectiveness, Safety and Tolerability of PREZISTA (Darunavir)/Ritonavir by Gender and Race When Administered With Other Antiretroviral Medications in Human Immunodeficiency Virus (HIV) Positive Women and Men.
Completed
Tibotec, Inc
Phase 3
2006-11-01
The purpose of this study is to evaluate any differences in the effectiveness, safety, and
tolerability of PREZISTA (darunavir; DRV) 600 mg, administered with ritonavir (RTV) 100 mg
twice a day on virologic response (defined as a viral load (VL) of < 50 copies/mL) over a
48-week treatment period in HIV-positive women and men. Additional antiretroviral (ARV)
agents will also be administered and will be chosen by the Investigator based on resistance
testing and prior treatment history (referred to as the Optimized Background Regimen (OBR)).
Study Comparing Efficacy and Safety of Darunavir Boosted With Ritonavir to HART With 2 NRTI and Darunavir Boosted With Ritonavir in HIV-1 Infected Patients ANRS136
Completed
Tibotec Pharmaceutical Limited
Phase 3
2007-03-01
The purpose of this study is to evaluate whether a monotherapy of boosted darunavir is able
to maintain the virological success until 48 weeks in comparison to a standard therapy 2 INTI
+ darunavir/r in HIV infected patients with full viral suppression.
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