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Sponsored by: |
Tibotec Pharmaceutical Limited |
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Information provided by: | Tibotec Pharmaceutical Limited |
ClinicalTrials.gov Identifier: | NCT00071097 |
The purpose of this study is to determine the effectiveness, safety, and tolerability (how well the body stands the drug) of an investigational protease inhibitor (PI) called TMC114 given with low dose ritonavir.
Condition | Intervention | Phase |
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HIV Infections |
Drug: TMC114/rtv |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Randomized, Controlled, Partially Blinded Trial to Investigate Dose Response of TMC114/RTV in 3-Class-Experienced HIV-1 Infected Patients, Followed by an Open-Label Period on the Recommended Dose of TMC114/RTV. |
Enrollment: | 319 |
Study Start Date: | October 2003 |
Study Completion Date: | November 2007 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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001: Experimental |
Drug: TMC114/rtv
400mg TMC114/100mg rtv once daily
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002: Experimental |
Drug: TMC114/rtv
800mg TMC114/100mg rtv once daily
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003: Experimental |
Drug: TMC114/rtv
400mg TMC114/100mg rtv both twice daily
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004: Experimental |
Drug: TMC114/rtv
600mg TMC114/100mg rtv twice daily
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005: No Intervention
Control
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A phase II randomized, controlled, partially blinded, trial to investigate dose response of TMC114/RTV in HIV-1 infected patients who have previously received all three licensed classes of HIV antiviral drugs (known as nucleoside reverse transcriptase inhibitors (NRTI), nonnucleoside reverse transcriptase inhibitors (NNRTI) and protease inhibitors (PI)), and who are on a stable PI-containing regimen not including an NNRTI may be eligible to participate. Four doses of TMC-114/ritonavir will be stuided. 300 patients in the United States and Puerto Rico will participate. The duration of the study is 96 weeks.
Randomize to one of 4 treatment groups (TMC114/RTV: 400/100 mg qd; 800/100mg qd; 400/100mg bid; 600/100 bid) or control arm for 24 to 48 wks. Optimal dose (TMC114/RTV 600/100mg bid) open label portion of the study. The trial was extended to include 144Wks of treatment.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Tibotec Pharmaceutical Limited ( Compound Development Team Leader TMC114 ) |
Study ID Numbers: | CR006778, TMC114-C202 |
Study First Received: | October 10, 2003 |
Last Updated: | October 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00071097 |
Health Authority: | United States: Food and Drug Administration |
Safety and efficacy HIV TMC114 |
TMC114-C211 Ritonavir Tolerability |
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 |