TMC125-C223: TMC125 in HIV-1 Infected Subjects
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Purpose
The purpose of this study is to investigate the ability of TMC125, a Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), to lower the amount of virus in your blood when administered twice daily for 48 weeks.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infection |
Drug: TMC125 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Primary Purpose: Treatment |
| Official Title: | A Randomized, Controlled, Partially Blinded Phase IIb Dose-Finding Trial of TMC125 in HIV-1 Infected Subjects With Documented Genotypic Evidence of Resistance to Currently Available NNRTIs and With at Least Three Primary PI Mutations |
- The primary objective of the trial is to evaluate the dose-response relationship of antiviral activity at 24 weeks within the two TMC125 dose regimens.
- Evaluate the antiviral activity, safety and tolerability of TMC125, immunologic changes, changes in viral genotype and drug suseptibility, PK of TMC125 and compare antiviral effect among treatment groups
| Enrollment: | 211 |
| Study Start Date: | March 2004 |
| Study Completion Date: | October 2005 |
TMC125 will be given in addition to a combination of anti-HIV drugs that have been selected specifically for you by your doctor. There are three treatment groups in the study. One group will be given a dosage of TMC125, 400 mg twice daily. Another will be given 800 mg twice daily. The third group, a control arm, will not receive TMC125 (formulation TF035). The safety, tolerability and pharmacokinetics (determinations of the concentration of drug in your blood and its evolution over time) of TMC125 will also be evaluated in this study. Patients who have known resistance to NNRTIs and 3 or more protease inhibitor (PI) mutations may be eligible to participate. One-hundred-fifty (150) patients will be enrolled into this study. TMC125, 400mg twice daily for 48 weeks; TMC125, 800mg twice daily for 48 weeks.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- HIV-1 plasma viral load at screening >1000 copies/ml
- Documented genotypic evidence of resistance to currently available NNRTIs
- Previous NRTI experience for at least 3 months
- 3 primary PI mutations at screening
Exclusion Criteria:
- Chronic HBV and/or HCV with elevated liver function tests > 3x upper normal limits
- Any grade 3 or 4 toxicity according to the ACTG grading severity list (except for grade 3 glucose and asymptomatic triglyceride/cholesterol grade 3 or 4 elevation)
- Previous permanent discontinuation of any NNRTI due to cutaneous events.
Contacts and Locations More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00081978 History of Changes |
| Other Study ID Numbers: | CR006736 |
| Study First Received: | April 28, 2004 |
| Last Updated: | April 26, 2010 |
| Health Authority: | United States: Food and Drug Administration Ireland: Irish Agriculture and Food Development Authority |
Keywords provided by Tibotec Pharmaceuticals, Ireland:
|
HIV infection TMC125 Non-nucleoside reverse transcriptase inhibitor, TMC125-C223 |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Slow Virus Diseases Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013