NCT00005915 - 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)

Anti-HIV agents
An attempt at treatment interruption--trial CPCRA 064. TreatmentUpdate. 2003 Aug-Sep;15(5):4-5.
Lawrence J, Hullsiek KH, Thackeray LM, Abrams DI, Crane LR, Mayers DL, Jones MC, Saldanha JM, Schmetter BS, Baxter JD
Disadvantages of structured treatment interruption persist in patients with multidrug-resistant HIV-1: final results of the CPCRA 064 st
Lawrence J, Mayers DL, Hullsiek KH, Collins G, Abrams DI, Reisler RB, Crane LR, Schmetter BS, Dionne TJ, Saldanha JM, Jones MC, Baxter JD; 064 Study Team of the Terry Beirn Community Programs for Clinical Research on AIDS
Structured treatment interruption in patients with multidrug-resistant human immunodeficiency virus. N Engl J Med. 2003 Aug 28;349(9):837-46.
Paquet AC, Baxter J, Weidler J, Lie Y, Lawrence J, Kim R, Bates M, Coakley E, Chappey C
Differences in reversion of resistance mutations to wild-type under structured treatment interruption and related increase in replication capacity. PLoS One. 2011 Jan

A Randomized Study of a Prescribed 4-Month Structured Treatment Interruption (STI) Followed by Initiation of a New Antiretroviral Regimen Versus Immediate Initiation of a New Antiretroviral Regimen in HIV-Infected Patients With Multidrug Resistant (MDR) Virus

Details for clinical trial NCT00005915

Clinical trial NCT00005915 - References