Post Marketing Surveillance on Safety and Efficacy of IMOD in Iranian Patients with HIV/AIDS

Minoo      Mohraz; Abbas      Sedaghat; SeyedAhmad      SeyedAlinaghi; Hossein      Asheri; Saeid      Mohammaddoust; Farhad      Gharibdoost; Hamid Reza   Khorram   Khorshid; Mohammad      Farhadi; Seyed   Hesamedin   Madani; Koorosh      Kamali

doi:10.2174/18715265112129990031

Abstract

Acquired Immune Deficiency Syndrome is one of the world's serious health problems. Immune-based therapy is a new approach in the treatment of HIV infected patients. IMOD^TM with the ability to correct immune deficiencies has been introduced for the management of HIV infection. In the phase IV trial study the main objectives were to assess the possible side effects, evaluate its effect on CD4+ T Lymphocyte count and patients’ and physicians’ satisfactions for 600 HIV infected patients in 13 centers during 2007. The observed adverse events in patients included: headache and vertigo (1.2%), nausea (1.2%), gastritis (1.2%), phlebitis (1%) and mild rash (1%); serious adverse events were not observed in any of IMODTM recipients. Therefore it was not needed to terminate the treatment in any of patient. The results of this study demonstrated that daily prescription of IMODTM significantly increases T Lymphocyte CD4+ and Total Lymphocyte Count in HIV-positive patients. In addition, nearly 90% of the patients and 70% physicians are satisfied by IMOD^TM treatment.

Keywords: Efficacy, IMOD^TM, post marketing surveillance, safety, satisfaction, side effect.