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Sponsors and Collaborators: |
Tibotec Pharmaceuticals Limited, Ireland Tibotec Pharmaceuticals |
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Information provided by: | Tibotec Pharmaceuticals Limited, Ireland |
ClinicalTrials.gov Identifier: | NCT00915655 |
The purpose of this Phase II trial is to evaluate pharmacokinetics ( blood levels), safety, tolerability, and efficacy of darunavir with low-dose ritonavir (DRV/rtv) administered once daily (q.d.), in combination with an investigator-selected background regimen consisting of 2 NRTIs, in treatment-naÃ-ve (never treated before) HIV 1 infected adolescents aged from 12 to < 18 years and weighing at least 40 kg
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: darunavir tablets Drug: ritonavir capsule |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study |
Official Title: | A Phase II, Open Label Trial, to Evaluate Pharmacokinetics, Safety, Tolerability and Antiviral Activity of DRV q.d. in Treatment-naïve HIV-1 Infected Adolescents Between 12 and < 18 Year of Age. |
Estimated Enrollment: | 12 |
Study Start Date: | July 2009 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
001: Experimental |
Drug: darunavir tablets
2 x 400 mg tablet once daily for 48 weeks
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002: Experimental |
Drug: ritonavir capsule
100 mg capsule once daily for 48 weeks
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Ages Eligible for Study: | 12 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: | info1@veritasmedicine.com |
United States, Tennessee | |
Recruiting | |
Memphis, Tennessee, United States | |
France | |
Not yet recruiting | |
Paris, France | |
Ireland | |
Not yet recruiting | |
Dublin, Ireland | |
Spain | |
Not yet recruiting | |
Madrid, Spain | |
Not yet recruiting | |
Esplugues De Llobregat, Spain | |
Ukraine | |
Not yet recruiting | |
Kiev, Ukraine | |
United Kingdom | |
Not yet recruiting | |
Bristol, United Kingdom | |
Not yet recruiting | |
Birmingham, United Kingdom | |
Not yet recruiting | |
Stoke On Trent, United Kingdom |
Study Director: | Tibotec Pharmaceuticals Limited Clinical Trial | Tibotec Pharmaceutical Limited |
Responsible Party: | Tibotec Pharmaceuticals Limited, Ireland ( Compound Development Team Leader ) |
Study ID Numbers: | CR016312, TMC114-TiDP29-C230 |
Study First Received: | June 4, 2009 |
Last Updated: | August 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00915655 History of Changes |
Health Authority: | United States: Food and Drug Administration; Ireland: Irish Agriculture and Food Development Authority |
TMC114-TiDP29-C230 TMC114-C230 TMC114 |
HIV darunavir ritonavir |
Anti-Infective Agents Sexually Transmitted Diseases, Viral HIV Protease Inhibitors Anti-HIV Agents Acquired Immunodeficiency Syndrome Antiviral Agents Immunologic Deficiency Syndromes Darunavir |
Protease Inhibitors Virus Diseases Anti-Retroviral Agents HIV Infections Ritonavir Sexually Transmitted Diseases Retroviridae Infections |
Anti-Infective Agents HIV Protease Inhibitors RNA Virus Infections Sexually Transmitted Diseases, Viral Anti-HIV Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Infection Antiviral Agents |
Pharmacologic Actions Darunavir Immunologic Deficiency Syndromes Protease Inhibitors Virus Diseases Anti-Retroviral Agents Ritonavir HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |