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Generated: December 19, 2018

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CLINICAL TRIALS PROFILE FOR PREZISTA

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Clinical Trials for Prezista

Trial ID Title Status Sponsor Phase Summary
NCT00381303 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 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)).
NCT00381303 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 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)).
NCT00460746 Enfuvirtide/Current Protease Inhibitor Switch to PREZISTA (Darunavir)/Ritonavir + TMC125 in HIV Patients With Enfuvirtide Side Effects. Completed Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA Phase 3 The purpose of this study is to examine the safety, tolerability, and effectiveness of darunavir/ritonavir combined with TMC125 when current protease inhibitor(s), Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI(s)) and enfuvirtide are replaced by darunavir/ritonavir and TMC125 in HIV positive patients who can no longer tolerate enfuvirtide and are experiencing viral suppression. Other antiviral drugs in the regimen are to remain unchanged.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Prezista

Condition Name

Condition Name for Prezista
Intervention Trials
HIV Infections 9
HIV 4
HIV-1 Infection 2
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Condition MeSH

Condition MeSH for Prezista
Intervention Trials
HIV Infections 16
Acquired Immunodeficiency Syndrome 7
Immunologic Deficiency Syndromes 4
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Clinical Trial Locations for Prezista

Trials by Country

Trials by Country for Prezista
Location Trials
United States 49
Canada 6
Argentina 4
Puerto Rico 3
Italy 3
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Trials by US State

Trials by US State for Prezista
Location Trials
California 5
New York 4
North Carolina 3
Maryland 3
Florida 3
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Clinical Trial Progress for Prezista

Clinical Trial Phase

Clinical Trial Phase for Prezista
Clinical Trial Phase Trials
Phase 4 7
Phase 3 5
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Prezista
Clinical Trial Phase Trials
Completed 14
Terminated 3
Recruiting 2
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Clinical Trial Sponsors for Prezista

Sponsor Name

Sponsor Name for Prezista
Sponsor Trials
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA 4
Tibotec, Inc 3
Merck Sharp & Dohme Corp. 2
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Sponsor Type

Sponsor Type for Prezista
Sponsor Trials
Other 21
Industry 19
NIH 3
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