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Generated: March 19, 2019

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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.
NCT00460746 Enfuvirtide/Current Protease Inhibitor Switch to PREZISTA (Darunavir)/Ritonavir + TMC125 in HIV Patients With Enfuvirtide Side Effects. Completed Tibotec, Inc 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.
NCT00517192 Comparison of TPV/r to DRV/r in Triple Class Experienced Patient With Resistance to > 1 PI Terminated Boehringer Ingelheim Phase 3 The objective of this study is to compare the efficacy and safety of Tipranavir/ritonavir (TPV/r, 500mg/200mg twice daily) to the safety and efficacy of Darunavir/ritonavir (DRV/r 600 mg /100 mg twice daily) in combination with investigator selected optimised background regimens in patients who are three-class (Nucleoside reverse transcriptase inhibitors (NRTI), Nonnucleoside reverse transcriptase inhibitors (NNRTI), and Protease inhibitor (PI)) treatment-experienced (a minimum of 3-months duration for each class) with resistance to more than one PI on the screening virtual phenotype resistance testing.
NCT00525733 Standard Antiretroviral v. Multi-class Therapy in Acutely HIV-1 Infected Antiretroviral-Naïve Subjects (ADARC 2007-01) Completed Aaron Diamond AIDS Research Center N/A The researchers are involved in a phase II, randomized, two-arm study, comparing the efficacy, safety, and tolerability of open-label ritonavir (RTV)-enhanced darunavir with Truvada to a 5-drug multi-class regimen including truvada, darunavir/ritonavir/maraviroc/and raltegravir on acutely HIV-1-infected, antiretroviral (ARV) drug-naïve men and women. Subjects will participate for at least 60 weeks and up to 96 weeks if in the opinion of the investigator and patient that continued therapy is in the patient's best interest. Hypotheses: - Multi-class antiretroviral therapy (ART) is superior to RTV-enhanced ATV in combination with Emtricitabine/Tenofovir DF (FTC/TDF) with respect to suppression of viral replication. - Multi-class ART is superior to RTV-enhanced ATV in combination with FTC/TDF with respect to immune reconstitution in peripheral blood and in the gastrointestinal mucosa. - Multi-class ART is equivalent to RTV-enhanced ATV in combination with FTC/TDF with respect to tolerability.
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
HIV 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
Infection 2
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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
Unknown status 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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