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Tenofovir Disoproxil Fumarate/Emtricitabine/Efavirenz Versus Combivir/Efavirenz in Antiretroviral-Naive HIV-1 Infected Subjects
Completed
Gilead Sciences
Phase 3
2003-07-01
The purpose of Study GS-01-934 was to assess the efficacy and safety of two simplified
antiretroviral treatment (ART) regimens in ART-naive, human immunodeficiency virus, type 1
(HIV-1) infected participants. The primary objective of the study was to assess
noninferiority of emtricitabine (FTC) and tenofovir disoproxil fumarate (tenofovir DF; TDF)
in combination with efavirenz (EFV) relative to Combivir (CBV) in combination with EFV in
the treatment of HIV-1 infected ART-naive participants, determined by the achievement and
maintenance of confirmed HIV-1 ribonucleic acid (RNA) < 400 copies/mL (c/mL) through Week
48, as defined by the United States (US) Food and Drug Administration (FDA)
time-to-loss-of-virologic-response (TLOVR) algorithm.
Safety and Durability ofTenofovir and a Cell Cycle Agent for Viral Suppression
Completed
University of Maryland
N/A
2003-06-01
Study Hypothesis Evaluation of the durability of the combination Tenofovir and Hydroxyurea
to maintain viral suppression below 50 copies/ml in volunteers who have achieved viral
suppression on a standard HAART regimen.
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)).
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