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Sponsored by: |
Tibotec Pharmaceuticals Limited, Ireland |
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Information provided by: | Tibotec Pharmaceuticals Limited, Ireland |
ClinicalTrials.gov Identifier: | NCT00513513 |
This is an open label study (no placebos are used; all patients will receive the true medication) to evaluate the effectiveness of TMC114/rtv in treatment naïve (never previously received anti-HIV drugs), HIV 1 infected patients.
Condition | Intervention | Phase |
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HIV Infections |
Drug: TMC114 (darunavir) / ritonavir |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Open Label Trial in Treatment naïve, HIV 1 Infected Subjects Who Will Receive TMC114/Rtv as a Monotherapy |
Estimated Enrollment: | 24 |
Study Start Date: | September 2006 |
Study Completion Date: | October 2007 |
Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
This is an open label (no placebo), uncontrolled (all patients will receive TMC114 with ritonavir at the same dose, trial to investigate the sustained anti-viral activity of TMC114/rtv monotherapy in 24 treatment naïve, HIV 1 infected patients over a period of 48 weeks.TMC114, 800 mg daily (2 tablets of 400 mg [F021]) will be given together with 1 capsule (100 mg) of ritonavir.Initially 11 subjects (Panel A, screening viral load between 10000 and 100000 copies/mL) will be included and followed for 8 weeks. If after 8 weeks of dosing at least 7 subjects virologically respond (viral load <400 copies/mL), 13 additional patients (Panel B) will be included. If no virologic failure is observed in at least 18 out of 24 patients who complete 8 weeks of dosing, the trial will continue as planned. In case more than 6 patients in Panel A and Panel B develop a virologic failure after 8 weeks of treatment, the trial will be stopped to conclude the treatment is not effective.The 13 additional patients enrolled in Panel B should have a screening viral load between 20000 and 500000 copies/mL. The CD4+ cell count in all 24 patients should be > 100 cells/µL at screening. The patient's medical condition, adverse events (side effects), study medication compliance, and laboratory evaluations for effectiveness and safety will be assessed at regular intervals. At the end of the 48 weeks treatment period patients will be followed for an additional 4 weeks to evaluate any side effects or laboratory abnormalities. Treatment with TMC114/rtv will be extended for all patients who continue to benefit after 48 weeks.
2 oral tablets of TMC114 400 mg will be administered once daily with 1 capsule (100mg) of ritonavir for 48 weeks.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CR010612 |
Study First Received: | August 6, 2007 |
Last Updated: | October 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00513513 |
Health Authority: | Ireland: Irish Agriculture and Food Development Authority |
HIV Protease inhibitor AIDS Antiretroviral agents |
Darunavir TMC114 Treatment Naive |
Virus Diseases Sexually Transmitted Diseases, Viral Ritonavir HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Darunavir Immunologic Deficiency Syndromes |
Anti-Infective Agents RNA Virus Infections HIV Protease Inhibitors Slow Virus Diseases Anti-HIV Agents Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Protease Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections |