NCT00001948 - 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)

Behrens G, Dejam A, Schmidt H, Balks HJ, Brabant G, Körner T, Stoll M, Schmidt RE
Impaired glucose tolerance, beta cell function and lipid metabolism in HIV patients under treatment with protease inhibitors. AIDS. 1999 Jul 9;13(10):F63-70.
Cella DF
Methods and problems in measuring quality of life. Support Care Cancer. 1995 Jan;3(1):11-22. Review.
Cunningham WE, Shapiro MF, Hays RD, Dixon WJ, Visscher BR, George WL, Ettl MK, Beck CK
Constitutional symptoms and health-related quality of life in patients with symptomatic HIV disease. Am J Med. 1998 Feb;104(2):129-36.

A Study of Health-Related Quality of Life in HIV-Infected Patients Undergoing Structured Treatment Interruptions of Highly Active Antiretroviral Therapy

Details for clinical trial NCT00001948

Clinical trial NCT00001948 - References