NCT00084032 - 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)

Girard PM, Schneider V, Dehée A, Mariot P, Jacomet C, Delphin N, Damond F, Carcelain G, Autran B, Saimot AG, Nicolas JC, Rozenbaum W
Treatment interruption after one year of triple nucleoside analogue therapy for primary HIV infection. AIDS. 2001 Jan 26;15(2):275-7.
Kaufmann GR, Zaunders JJ, Cunningham P, Kelleher AD, Grey P, Smith D, Carr A, Cooper DA
Rapid restoration of CD4 T cell subsets in subjects receiving antiretroviral therapy during primary HIV-1 infection. AIDS. 2000 Dec 1;14(17):2643-51.
Malhotra U, Berrey MM, Huang Y, Markee J, Brown DJ, Ap S, Musey L, Schacker T, Corey L, McElrath MJ
Effect of combination antiretroviral therapy on T-cell immunity in acute human immunodeficiency virus type 1 infection. J Infect Dis. 2000 Jan;181(1):121-31.
Markowitz M, Jin X, Hurley A, Simon V, Ramratnam B, Louie M, Deschenes GR, Ramanathan M Jr, Barsoum S, Vanderhoeven J, He T, Chung C, Murray J, Perelson AS, Zhang L, Ho DD
Discontinuation of antiretroviral therapy commenced early during the course of human immunodeficiency virus type 1 infection, with or without adjunctive vaccination. J Infect Dis. 2002 Sep 1;186(5):634-43. Epub 2002 Aug 9.
Walensky RP, Goldie SJ, Sax PE, Weinstein MC, Paltiel AD, Kimmel AD, Seage GR 3rd, Losina E, Zhang H, Islam R, Freedberg KA
Treatment for primary HIV infection: projecting outcomes of immediate, interrupted, or delayed therapy. J Acquir Immune Defic Syndr. 2002 Sep 1;31(1):27-37.

A Randomized, Multicenter Trial to Determine Whether Induction Therapy Followed by Treatment Interruption is Superior to Induction Therapy Alone in the Treatment of Primary HIV Infection (PHI): The Structured Treatment Interruption (STI) Study

Details for clinical trial NCT00084032

Clinical trial NCT00084032 - References