CLINICAL TRIALS PROFILE FOR DARUNAVIR
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505(b)(2) Clinical Trials for DARUNAVIR
| 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. |
| New Formulation | NCT06139796 ↗ | Pharmacokinetics Safety and Acceptability of DRV/r for Children Living With HIV | Not yet recruiting | AMS-PHPT Research Collaboration | Phase 1/Phase 2 | 2024-06-01 | The UNIVERSAL2 study is a research project designed to evaluate a newly developed formulation of an approved drug for children living with HIV aged over 3 years and weighing between 10 and 25 kg. The aim of UNIVERSAL2 is to determine the right dosage of this new formulation. |
| New Formulation | NCT06139796 ↗ | Pharmacokinetics Safety and Acceptability of DRV/r for Children Living With HIV | Not yet recruiting | Baylor College of Medicine | Phase 1/Phase 2 | 2024-06-01 | The UNIVERSAL2 study is a research project designed to evaluate a newly developed formulation of an approved drug for children living with HIV aged over 3 years and weighing between 10 and 25 kg. The aim of UNIVERSAL2 is to determine the right dosage of this new formulation. |
| New Formulation | NCT06139796 ↗ | Pharmacokinetics Safety and Acceptability of DRV/r for Children Living With HIV | Not yet recruiting | Centre Hospitalier National d'Enfants Albert Royer | Phase 1/Phase 2 | 2024-06-01 | The UNIVERSAL2 study is a research project designed to evaluate a newly developed formulation of an approved drug for children living with HIV aged over 3 years and weighing between 10 and 25 kg. The aim of UNIVERSAL2 is to determine the right dosage of this new formulation. |
| New Formulation | NCT06139796 ↗ | Pharmacokinetics Safety and Acceptability of DRV/r for Children Living With HIV | Not yet recruiting | Centre Mère et Enfant de la Fondation Chantal Biya | Phase 1/Phase 2 | 2024-06-01 | The UNIVERSAL2 study is a research project designed to evaluate a newly developed formulation of an approved drug for children living with HIV aged over 3 years and weighing between 10 and 25 kg. The aim of UNIVERSAL2 is to determine the right dosage of this new formulation. |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >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 | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for DARUNAVIR
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