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Sponsored by: |
Tibotec Pharmaceutical Limited |
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Information provided by: | Tibotec Pharmaceutical Limited |
ClinicalTrials.gov Identifier: | NCT00128830 |
This is a Phase II, open-label, roll-over trial to evaluate the long-term safety and tolerability of TMC125, administered as part of an individually optimized antiretroviral therapy (ART), in HIV-1 infected subjects. In addition, the antiviral activity and immunologic effect of TMC125 as part of an ART over time, and the genotypic and phenotypic changes over time will be evaluated.
Condition | Intervention | Phase |
---|---|---|
HIV Infection |
Drug: TMC-125 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label Trial With TMC125 in HIV-1 Infected Subjects, Who Were Randomized to a TMC125 Treatment Arm in a Sponsor-Selected TMC125 Trial and Were Treated for at Least 48 Weeks. |
Estimated Enrollment: | 300 |
Study Start Date: | June 2005 |
Estimated Study Completion Date: | August 2008 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
001: Experimental |
Drug: TMC-125
200mg TMC125 twice daily until commercially available
|
This is a Phase II, open-label, roll-over trial to evaluate the long-term safety and tolerability of TMC125, administered as part of an individually optimized antiretroviral therapy (ART), in HIV-1 infected subjects. In addition, the antiviral activity and immunologic effect of TMC125 as part of an ART over time, and the genotypic and phenotypic changes over time will be evaluated. Patient who were randomized to a TMC125 treatment arm in a sponsor-selected TMC125 trial, were treated for at least 48 weeks with TMC125, and who may derive continued benefit from TMC125 therapy, as judged by the investigator, can be enrolled. Based on the currently selected trials approximately 300 subjects can be enrolled in the current trial. 800mg twice daily of TMC125 (formulation TF035) and after formulation switch, 200 mg twice daily (formulation F060) will be given in combination with an investigator-selected, optimized underlying therapy (NRTIs and/or allowed PIs and/or T-20). Tolerability and safety will be assessed throughout the trial and the efficacy parameters will be determined at defined time points during the trial.
TMC125, 800 mg twice a day and after formulation switch, at 200 mg twice a day
Ages Eligible for Study: | 18 Years and older |
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 |
Study Director: | Tibotec Clinical Trial | Tibotec Pharmaceutical Limited |
Responsible Party: | Tibotec Pharmaceuticals Limited ( Compound Development Team Leader TMC125 ) |
Study ID Numbers: | CR002731, TMC125-C229 |
Study First Received: | August 8, 2005 |
Last Updated: | September 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00128830 |
Health Authority: | United States: Food and Drug Administration |
Antiretroviral therapy HIV-1 infection TMC125 roll-over study |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |