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Sponsored by: |
Tibotec Pharmaceutical Limited |
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Information provided by: | Tibotec Pharmaceutical Limited |
ClinicalTrials.gov Identifier: | NCT00111280 |
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, in HIV 1 infected subjects. In addition, the antiviral activity and immunological effect of TMC125 as part of an antiretroviral regimen over time, and the evolution of HIV phenotype and genotype will be evaluated.
Condition | Intervention | Phase |
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HIV Infection |
Drug: TMC125 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | HIV-1 Infected Subjects Who Were Randomized in Any Sponsor-Selected TMC125 Trial to an Active Control Arm and Either Virologically Failed or Completed the Entire Treatment Period, or to Placebo Arm and Were Treated for at Least 48 Weeks. |
Estimated Enrollment: | 170 |
Study Start Date: | September 2004 |
Study Completion Date: | March 2007 |
The purpose of this Phase II, open-label, roll-over trial is to evaluate the long term safety and tolerability of TMC125, administered as part of an individually optimized antiretroviral therapy, in HIV 1 infected subjects. In addition, the antiviral activity and immunological effect of TMC125 as part of an antiretroviral regimen over time, and the evolution of HIV phenotype and genotype will be evaluated. Subjects who were randomized to an active control arm of any sponsor-selected TMC125 trial and virologically failed or completed the entire treatment period, or to placebo arm and were treated for at least 48 and who may derive benefit from TMC125 treatment as judged by the investigator can be enrolled. Based on the currently selected studies, a maximum of 170 subjects will be enrolled in the current trial. A dose of 800mg b.i.d . of TMC125 (formulation TF035) and after the formulation switch, 200mg b.i.d. (formulation F060), will be given in combination with an investigator-selected, optimized underlying therapy starting at baseline and consisting of at least 2 drugs (nucleoside reverse transcriptase inhibitors [NRTIs] and/or allowed protease inhibitors [PIs] and/or enfuvirtide [T 20]) for 48 weeks. Tolerability and safety will be assessed throughout the trial. The efficacy parameters will be determined at defined time points during the trial. The trial will involve a screening visit preferable on the same day as the withdrawal visit of the sponsor-selected trial, a baseline visit, a treatment period of 48 weeks, a final visit and a 4 week follow-up period.
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:
Study ID Numbers: | CR006742 |
Study First Received: | May 18, 2005 |
Last Updated: | January 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00111280 History of Changes |
Health Authority: | Ireland: Irish Agriculture and Food Development Authority; United States: Food and Drug Administration |
roll-over trial TMC125 HIV infection antiretrovirals (ARVs) Nucleoside reverse transcriptase inhibitors (NRTIs) |
Virus Diseases Sexually Transmitted Diseases, Viral Anti-Retroviral Agents HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Antiviral Agents Retroviridae Infections Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors |
Anti-Infective Agents RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Infection Antiviral Agents Pharmacologic Actions |
Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors Virus Diseases Anti-Retroviral Agents HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections Nucleic Acid Synthesis Inhibitors |