Safety and Tolerability of Pegylated Interferon (PEG-IFN) Alfa-2a in HIV Infected People

Summary

Recombinant interferon (IFN) may be useful in the treatment of HIV. However, the high doses of IFN necessary to keep HIV under control limit its use due to toxic side effects. The purpose of this study is to test the safety and tolerability of weekly recombinant pegylated interferon (PEG-IFN) alfa-2a in HIV infected people who are currently on antiretroviral therapy (ART) interruption or who have not started taking anti-HIV drugs.

Timeline

Start

2006-05

Primary completion

2007-01

Completion

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Publications

• Background Bain VG. Effect of HCV viral dynamics on treatment design: lessons learned from HIV. Am J Gastroenterol. 2001 Oct;96(10):2818-28. doi: 10.1111/j.1572-0241.2001.04234.x.
• Background Dwyer JT, Paul SM. HIV and hepatitis C co-infection. N J Med. 2003 Sep;100(9 Suppl):50-4; quiz 77-8.
• Background 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. doi: 10.1097/00002030-200107270-00014.
• Background Kawakami K. Promising immunotherapies with Th1-related cytokines against infectious diseases. J Infect Chemother. 2003 Sep;9(3):201-9. doi: 10.1007/s10156-003-0263-5.
• Background Levy JA, Scott I, Mackewicz C. Protection from HIV/AIDS: the importance of innate immunity. Clin Immunol. 2003 Sep;108(3):167-74. doi: 10.1016/s1521-6616(03)00178-5. No abstract available.
• Asmuth DM, Murphy RL, Rosenkranz SL, Lertora JJ, Kottilil S, Cramer Y, Chan ES, Schooley RT, Rinaldo CR, Thielman N, Li XD, Wahl SM, Shore J, Janik J, Lempicki RA, Simpson Y, Pollard RB; AIDS Clinical Trials Group A5192 Team. Safety, tolerability, and mechanisms of antiretroviral activity of pegylated interferon Alfa-2a in HIV-1-monoinfected participants: a phase II clinical trial. J Infect Dis. 2010 Jun 1;201(11):1686-96. doi: 10.1086/652420.

Drugs

Indications