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

Infect Disord Drug Targets. 2013 Feb;13(1):71-4. 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™ 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.

Publication types

  • Clinical Trial, Phase IV
  • Multicenter Study

MeSH terms

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

Substances

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