Post marketing surveillance on safety and efficacy of IMOD in Iranian patients with HIV/AIDS.

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™ 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 IMOD™ recipients. Therefore it was not needed to terminate the treatment in any of patient. The results of this study demonstrated that daily prescription of IMOD™ 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™ treatment.

• Authors: Minoo Mohraz, Abbas Sedaghat, SeyedAhmad SeyedAlinaghi, Hossein Asheri, Saeid Mohammaddoust, Farhad Gharibdoost, Hamid Reza Khorram Khorshid, Mohammad Farhadi, Seyed Hesamedin Madani, Koorosh Kamali
• Journal: Infectious disorders drug targets (Infect Disord Drug Targets) Vol. 13 Issue 1 Pg. 71-4 (Feb 2013) ISSN: 2212-3989 [Electronic] United Arab Emirates
• PMID: 23713668 (Publication Type: Clinical Trial, Phase IV, Journal Article, Multicenter Study)

Chemical References

• Anti-HIV Agents
• Anti-Retroviral Agents
• Plant Extracts
• setarud

Topics

• Acquired Immunodeficiency Syndrome (blood, drug therapy, immunology)
• Anti-HIV Agents (administration & dosage, adverse effects, therapeutic use)
• Anti-Retroviral Agents (therapeutic use)
• Attitude of Health Personnel
• CD4 Lymphocyte Count
• Drug Therapy, Combination (adverse effects)
• Female
• HIV Infections (blood, drug therapy, immunology)
• Humans
• Immunomodulation (drug effects)
• Infusions, Intravenous
• Iran
• Lymphocyte Count
• Male
• Patient Satisfaction
• Physicians
• Plant Extracts (administration & dosage, adverse effects, therapeutic use)
• Product Surveillance, Postmarketing