HIV Clinical Trial
Official title:
A Phase III Randomized, Double-blinded, Placebo-controlled Trial to Investigate the Efficacy, Tolerability and Safety of TMC125 as Part of an ART Regimen, Including TMC114/RTV and an Investigator-selected OBR, in HIV-1 Infected Patients With Limited Treatment to no Treatment Options.
The purpose of this study is research with the goal of evaluating the effect of TMC125 (a non-nucleoside reverse transcriptase inhibitor) on slowing down the growth of the HIV virus. The study will also investigate whether this new medication is well tolerated, and to further confirm that the medication is safe to be used.
Status | Completed |
Enrollment | 616 |
Est. completion date | July 2008 |
Est. primary completion date | February 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patient has 3 or more primary protease inhibitor mutations - documented genotypic evidence of resistance to currently available NNRTIs by having at least 1 NNRTI (non-nucleoside reverse transcriptase inhibitors) resistance-associated mutation - on a stable antiretroviral therapy for at least 8 weeks - plasma viral load at screening visit > 5000 HIV-1 RNA copies/mL. Exclusion Criteria: - Active AIDS defining illnesses (except for stable, cutaneous Kaposi's Sarcoma or wasting syndrome) - Any grade 3 or grade 4 toxicity according to the DAIDS grading scale - Use of disallowed concurrent therapy - Any active clinically significant disease |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Tibotec Pharmaceuticals, Ireland |
United States, Argentina, Brazil, Chile, Costa Rica, France, Mexico, Panama, Puerto Rico, Thailand,
Katlama C, Haubrich R, Lalezari J, Lazzarin A, Madruga JV, Molina JM, Schechter M, Peeters M, Picchio G, Vingerhoets J, Woodfall B, De Smedt G; DUET-1, DUET-2 study groups. Efficacy and safety of etravirine in treatment-experienced, HIV-1 patients: pooled — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of efficacy, tolerability and safety of TMC125 as part of an antiretroviral therapy containing TMC114/ritonavir and an investigator selected optimized background regimen. | 24 weeks | No |
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