NCT00050856 - 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)

Durant J, Clevenbergh P, Halfon P, Delgiudice P, Porsin S, Simonet P, Montagne N, Boucher CA, Schapiro JM, Dellamonica P
Drug-resistance genotyping in HIV-1 therapy: the VIRADAPT randomised controlled trial. Lancet. 1999 Jun 26;353(9171):2195-9. Erratum in: Lancet 1999 Sep 25;354(9184):1128.
Mitsuya H, Yarchoan R, Broder S
Molecular targets for AIDS therapy. Science. 1990 Sep 28;249(4976):1533-44. Review.
Palella FJ Jr, Delaney KM, Moorman AC, Loveless MO, Fuhrer J, Satten GA, Aschman DJ, Holmberg SD
Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. HIV Outpatient Study Investigators. N Engl J Med. 1998 Mar 26;338(13):853-60.

Multicenter, Open-Label, Early Acces Program of Fuzeon (Enfuvirtide T-20/Ro 29,9800, HIV-1 Fusion Inhibitor) in Combination With Free Choice Antiretroviral Regimen to Assess Serious Adverse Events, Serious AIDS-Defining Events, and Tolerability in Patient

Details for clinical trial NCT00050856

Clinical trial NCT00050856 - References