NCT00031343 - 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)

Alter MJ, Margolis HS, Krawczynski K, Judson FN, Mares A, Alexander WJ, Hu PY, Miller JK, Gerber MA, Sampliner RE, et al
The natural history of community-acquired hepatitis C in the United States. The Sentinel Counties Chronic non-A, non-B Hepatitis Study Team. N Engl J Med. 1992 Dec 31;327(27):1899-905.
Alter MJ, Mast EE
The epidemiology of viral hepatitis in the United States. Gastroenterol Clin North Am. 1994 Sep;23(3):437-55. Review.
National Institutes of Health Consensus Development Conference Panel statement: management of hepatitis C
Hepatology. 1997 Sep;26(3 Suppl 1):2S-10S. Review.

A Randomized, Controlled Study to Assess the Impact of Highly Active Antiretroviral Therapy to Hepatitis C Therapy in Patients Coinfected With HIV-1 and Treated With Peginterferon Alpha-2b and Ribavirin

Details for clinical trial NCT00031343

Clinical trial NCT00031343 - References