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Sponsored by: |
Tibotec Pharmaceutical Limited |
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Information provided by: | Tibotec Pharmaceutical Limited |
ClinicalTrials.gov Identifier: | NCT00110877 |
Study TMC114-C214 is a randomized, controlled, open-label trial to compare the efficacy, safety and tolerability of TMC114 boosted with low dose ritonavir (RTV) versus Kaletra (LPV)/RTV in lopinavir-naïve treatment-experienced HIV-1 infected patients.
Condition | Intervention | Phase |
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HIV Infection |
Drug: LPV/rtv Drug: TMC114/rtv |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Controlled, Open-Label Trial to Compare the Efficacy, Safety and Tolerability of TMC114/RTV Versus LPV/RTV in Treatment-Experienced HIV-1 Infected Patients |
Estimated Enrollment: | 500 |
Study Start Date: | April 2005 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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001: Experimental |
Drug: TMC114/rtv
Two 300mg TMC114 tablets twice daily with 100mg RTV
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002: Experimental |
Drug: LPV/rtv
One 400mg LPV tablet twice daily with 100mg RTV
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Study TMC114-C214 is a randomized (patients are assigned to different treatment groups based on chance), controlled, open-label trial to compare the efficacy (effectiveness), safety and tolerability of TMC114 boosted with low dose ritonavir (RTV) versus Kaletra (LPV)/RTV in treatment-experienced HIV-1 infected patients. This research study will look at the safety of TMC114 and effectiveness in reducing the amount of HIV(viral load) in the blood.
People included in this study will have received either Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) or Protease Inhibitors (PIs) or both.
The duration of the study will be approximately 106 weeks, which includes a 4 to 6 week screening period, 96-week treatment period, and 4-week follow-up period.
TMC114 300mg are orange tablets where 2 tablets are taken by mouth twice a day with 1 tablet of Ritonavir. Kaletra (LPV/RTV) is either a tablet or capsule taken twice a day. The oral capsule contains 133.3 mg LPV, 33.3 mg RTV and the film-coated tablet is available for oral administration in a strength of 200 mg of lopinavir and 50 mg of ritonavir. Dosing for all medication will occur for 96 weeks and you will be randomly assigned to either TMC114 or Kaletra.
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: | CR002794, TMC114-C214 |
Study First Received: | May 13, 2005 |
Last Updated: | October 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00110877 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Human Immunodeficiency Virus Treatment Experienced TMC114-C214 |
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 Immunologic Deficiency Syndromes Darunavir Protease Inhibitors Virus Diseases Anti-Retroviral Agents HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |