Status:
COMPLETED
TMC125-C203: Phase II Randomized (Patients Are Assigned Different Treatments Based on Chance), Placebo Controlled Dose Escalating Trial of TMC125 in HIV-1 Infected Patients
Lead Sponsor:
Tibotec Pharmaceuticals, Ireland
Conditions:
Anti-Retroviral Agents
HIV-1
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this randomized (patients are assigned different treatments based on chance), placebo-controlled, dose-escalating trial is to evaluate the safety, tolerability and efficacy of different...
Detailed Description
Study TMC125-C203 is a phase II, randomized, placebo-controlled, dose-escalating trial that will be conducted in 2 stages. In total approximately two-hundred and fifty HIV-1 positive patients will be ...
Eligibility Criteria
Inclusion
- Plasma viral load at screening visit is above 1,000 HIV-1 RNA copies/ml
- Prior use of NRTI, NNRTI and PI, each for at least 3 months
- Currently receiving a stable (for 8 weeks) ART consisting of at least 3 antiretroviral drugs or currently on a treatment interruption for at least 8 weeks
- Further treatment options as defined by sensitivity to at least 2 antiretroviral drugs based on VirtualPhenotype™
Exclusion
- Active AIDS defining illnesses
- Patients with a history of severe allergy, hypersensitivity or dermatological manifestation that led to discontinuation while receiving any NNRTI or abacavir
- Pregnant or breast-feeding female
- Female of childbearing potential without the use of effective birth control methods
- Any toxicity above grade 2, except for lipids and glucose, according to the ACTG grading severity
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT00412646
Start Date
June 1 2002
End Date
November 1 2006
Last Update
April 28 2010
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