NCT00412646 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Montaner J, Yeni P, Clumeck NN, Fätkenheuer G, Gatell J, Hay P, Seminari E, Peeters MP, Schöller-Gyüre M, Simonts M, Woodfall B; TMC125-C203 Study Group
Safety, tolerability, and preliminary efficacy of 48 weeks of etravirine therapy in a phase IIb dose-

A Randomized, Placebo-controlled Phase II Trial in HIV-1-infected, NRTI-, PI and NNRTI-experienced Subjects to Evaluate the Safety, Tolerability and Efficacy of Different Doses of TMC125 b.i.d. on Top of an Individually Optimized Antiretroviral Therapy by Means of a 2-stage Dose-escalating Design

Details for clinical trial NCT00412646

Clinical trial NCT00412646 - References