NCT00078442 - 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)

Bain VG
Effect of HCV viral dynamics on treatment design: lessons learned from HIV. Am J Gastroenterol. 2001 Oct;96(10):2818-28. Review.
Dwyer JT, Paul SM
HIV and hepatitis C co-infection. N J Med. 2003 Sep;100(9 Suppl):50-4; quiz 77-8. Review.
Emilie D, Burgard M, Lascoux-Combe C, Laughlin M, Krzysiek R, Pignon C, Rudent A, Molina JM, Livrozet JM, Souala F, Chene G, Grangeot-Keros L, Galanaud P, Sereni D, Rouzioux C; Primoferon A Study Group
Early control of HIV replication in primary HIV-1 infection treated with antiretroviral drugs and pegylated IFN alpha: results from the Primoferon A (ANRS 086) Study. AIDS. 2001 Jul 27;15(11):1435-7.
Kawakami K
Promising immunotherapies with Th1-related cytokines against infectious diseases. J Infect Chemother. 2003 Sep;9(3):201-9. Review.
Levy JA, Scott I, Mackewicz C
Protection from HIV/AIDS: the importance of innate immunity. Clin Immunol. 2003 Sep;108(3):167-74. Review.

A Phase II Open-Label Pilot Trial of the Antiretroviral Activity, Safety, and Tolerability of Pegylated Interferon Alfa-2A (40KD) [PegasysTM] in HIV-1 Infected Subjects

Details for clinical trial NCT00078442

Clinical trial NCT00078442 - References