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Last Updated: June 30, 2022

CLINICAL TRIALS PROFILE FOR DARUNAVIR


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505(b)(2) Clinical Trials for Darunavir

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT01052883 ↗ TMC114-TiDP3-C182 - A Study to Compare the Oral Bioavailability of a 800 mg Prototype Tablet Formulation of Darunivar (DRV) to That of the 400 mg Commercial Tablet Formulation in the Presence of Low Dose Ritonavir, Under Fasted and Fed Conditions Completed Tibotec Pharmaceuticals, Ireland Phase 1 2010-03-01 The purpose of this study is to compare the drug levels of darunavir obtained after administration of a single administration of the 800 mg tablet (new formulation) to that following administration of two 400 mg commercial tablets formulation when administered under fed and fasted conditions to those also taking low-dose ritonavir. Darunavir is marketed for the treatment of HIV. The short-term safety and tolerability of darunavir following administration of a single 800 mg dose of darunavir given to healthy volunteers taking taking low-dose ritonavir will also be assessed.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Darunavir

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00039741 ↗ Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 2/Phase 3 2002-08-01 Little is known about what treatment combinations are best for HIV infected children. This study examined the long-term effectiveness of different anti-HIV drug combinations in children and strategies for switching treatment if the first treatment does not work. The study enrolled children who had not previously taken anti-HIV medication. Participants in this study were recruited in the United States, South America and Europe. Some European children may also enroll in a substudy that will observe changes in body fat in children taking anti-HIV medications.
NCT00039741 ↗ Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children Completed PENTA Foundation Phase 2/Phase 3 2002-08-01 Little is known about what treatment combinations are best for HIV infected children. This study examined the long-term effectiveness of different anti-HIV drug combinations in children and strategies for switching treatment if the first treatment does not work. The study enrolled children who had not previously taken anti-HIV medication. Participants in this study were recruited in the United States, South America and Europe. Some European children may also enroll in a substudy that will observe changes in body fat in children taking anti-HIV medications.
NCT00039741 ↗ Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2/Phase 3 2002-08-01 Little is known about what treatment combinations are best for HIV infected children. This study examined the long-term effectiveness of different anti-HIV drug combinations in children and strategies for switching treatment if the first treatment does not work. The study enrolled children who had not previously taken anti-HIV medication. Participants in this study were recruited in the United States, South America and Europe. Some European children may also enroll in a substudy that will observe changes in body fat in children taking anti-HIV medications.
NCT00081588 ↗ An Open Label Trial of TMC114/RTV in HIV-1 Infected, Treatment-experienced Subjects. Completed Tibotec Pharmaceuticals, Ireland Phase 2 2003-11-01 The primary objective of the TMC114-C215 study is to evaluate the safety and tolerability of TMC114/RTV over time. The secondary objectives are to evaluate the antiviral activity over time and to evaluate the immunological effect over time.
NCT00260078 ↗ Blood Levels of Anti-HIV Drugs Used in Combination Regimens in HIV Infected Children Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 1/Phase 2 2006-02-01 Limited data exist about combination anti-HIV treatment regimens in children, including how those drugs are cleared by the body in children. The purpose of this study is to measure the blood levels of the following combinations of anti-HIV drugs in HIV infected chilren: tenofovir disoproxil fumurate (TDF) and efavirenz (EFV) or nevirapine (NVP); TDF and darunavir (DRV) with or without EFV; and TDF and ritonavir (RTV) with or without EFV.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Darunavir

Condition Name

Condition Name for Darunavir
Intervention Trials
HIV Infections 54
HIV 32
HIV-1 Infection 15
HIV Infection 15
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Condition MeSH

Condition MeSH for Darunavir
Intervention Trials
HIV Infections 113
Acquired Immunodeficiency Syndrome 48
Immunologic Deficiency Syndromes 33
Infections 23
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Clinical Trial Locations for Darunavir

Trials by Country

Trials by Country for Darunavir
Location Trials
United States 577
Spain 51
Canada 37
United Kingdom 32
France 31
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Trials by US State

Trials by US State for Darunavir
Location Trials
Texas 41
California 39
New York 35
Florida 33
Massachusetts 31
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Clinical Trial Progress for Darunavir

Clinical Trial Phase

Clinical Trial Phase for Darunavir
Clinical Trial Phase Trials
Phase 4 61
Phase 3 43
Phase 2/Phase 3 7
[disabled in preview] 34
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Clinical Trial Status

Clinical Trial Status for Darunavir
Clinical Trial Phase Trials
Completed 154
Terminated 16
Recruiting 15
[disabled in preview] 20
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Clinical Trial Sponsors for Darunavir

Sponsor Name

Sponsor Name for Darunavir
Sponsor Trials
ViiV Healthcare 14
Gilead Sciences 14
Merck Sharp & Dohme Corp. 14
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Sponsor Type

Sponsor Type for Darunavir
Sponsor Trials
Other 216
Industry 167
NIH 19
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