NCT00006412 - 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)

Aberg JA, Zackin RA, Brobst SW, Evans SR, Alston BL, Henry WK, Glesby MJ, Torriani FJ, Yang Y, Owens SI, Fichtenbaum CJ; ACTG 5087 Study Team
A randomized trial of the efficacy and safety of fenofibrate versus pravastatin in HIV-infected subjects with li
Evans SR, Fichtenbaum CJ, Aberg JA; A5087 Study Team
Comparison of direct and indirect measurement of LDL-C in HIV-infected individuals: ACTG 5087. HIV Clin Trials. 2007 Jan-Feb;8(1):45-52.
Fichtenbaum CJ, Yeh TM, Evans SR, Aberg JA
Treatment with pravastatin and fenofibrate improves atherogenic lipid profiles but not inflammatory markers in ACTG 5087. J Clin Lipidol. 2010 Jul-Aug;4(4):279-87. doi: 10.1016/j.jacl.2010.04.003.

A Prospective, Multicenter, Randomized Trial Comparing the Efficacy and Safety of Fenofibrate Versus Pravastatin in HIV-Infected Subjects With Lipid Abnormalities

Details for clinical trial NCT00006412

Clinical trial NCT00006412 - References