The effects of setarud on the immunological status of HIV-positive patients: Efficacy of a novel multi-herbal drug

Document Type: Original Research Article

Authors

1 Young Researchers and Elites Club, Qom Branch, Islamic Azad University, Qom, I. R. Iran

2 Infectious disease specialist, Qom University of Medical Sciences, Qom, I. R. Iran.

3 Nursing Care Research Center in Chronic Diseases, School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, I. R. Iran

Abstract

Objective: This study examines the effect of the addition of IMOD, a novel multi-herbal drug to the highly active anti-retroviral therapy (HAART) regimen, on the immunological status of HIV-positive patients.
Materials and Methods: A randomized two-parallel-group (HAART group versus HAART+IMOD group), pretest-posttest design was used.
Sixty patients with indications for treatment with the HAART regimen participated. One week before and 2 days after the treatments, immunological parameters including total lymphocyte count (TLC) and CD4 cell count were assessed.
The intervention group received the HAART regimen plus IMOD every day for 3 months. The control group received only the HAART regimen every day for 3 months.
Results: In the intervention group, a significant difference was observed in CD4between before and after drug therapy (CD4 was increased). However, in the control group, the difference in CD4 was not significant before and after drug therapy. The difference in TLC was not significantly different between the two groups before and after therapy. Nevertheless, TLC was higher in the intervention group.
Conclusion: IMOD (as a herbal drug) has been successfully added to the HAART regimen to improve the immunological status of HIV-positive patients.

Keywords

Main Subjects


Panel on Antiretroviral Guidelines for Adults and Adolescents. 2008. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services, 1–139. www.aidsinfo.nih.gov/ContentFiles/ AdultandAdolescentGL.pdf.

Azonov J, Khorram Khorshid H, Novitsky Y, Farhadi M, Ghorbanoghli Z, Shahhosseiny M. 2008. Protective effects of setarud (IMODTM) on development of diet-induced hypercholesterolemia in rabbits. DARU J, 16:218-222.

Bangsberg DR, Moss AR, Deeks SG .2004. Paradoxes of adherence and drug resistance to HIV antiretroviral therapy. J Antimicrob Chemother, 53:696-699.

Barbaro G, Barbarini G .2011. Human immunodeficiency virus & cardiovascular risk. Indian J Med Res, 134:898-903.

Burgoyne RW, Tan DHS .2008. Prolongation and quality of life for HIV-infected adults treated with highly active antiretroviral therapy (HAART): a balancing act. J Antimicrob Chemother, 61:469-473.

Cerqueira DM, Amorim RM, Silva RR, Camara GN, Brígido MM, Martins CR .2004. Antiretroviral resistance and genetic diversity of human immunodeficiency virus type 1 isolates from the Federal District, Central Brazil. Mem Inst Oswaldo Cruz, 99:877-882.

Dybul M, Fauci AS, Bartlett JG, Kaplan JE, Pau AK. 2002. Guidelines for Using Antiretroviral Agents among HIV-Infected Adults and Adolescents: The Panel on Clinical Practices for Treatment of HIV*. Ann Intern Med, 137:381-433.

Egger M, May M, Chêne G. 2002. Prognosis of HIV-1-infected patients starting highly active antiretroviral therapy: a collaborative analysis of prospective studies. Lancet, 360:119-129.

Fellay J, Ledergerber B, Ledergerber B, Bernasconi E, Furrer H, Battegay M, Hirschel B, Vernazza P, Francioli P, Greub G, Flepp M, Telenti A. 2001. Prevalence of adverse events associated with potent antiretroviral treatment: Swiss HIV Cohort Study. Lancet, 358:1322-1327.

Gengis EH, Deeks SG .2009. CD4+ T Cell Recovery with Antiretroviral Therapy: More Than the Sum of the Parts. Clin Infect Dis, 48:362-64.

Gertsch J, Viveros-Paredes JM, Taylor P .2011. Plant immunostimulants—Scientific paradigm or myth? J Ethnopharmacol, 136:385-391.

Hammer SM, Eron JJ Jr, Reiss P, Schooley RT, Thompson MA, Walmsley S, Cahn P, Fischl MA, Gatell JM, Hirsch MS, Jacobsen DM, Montaner JS, Richman DD, Yeni PG, Volberding PA. 2008. Antiretroviral treatment of adult hiv infection: 2008 recommendations of the international aids society–usa panel. JAMA, 300:555-570.

Ho DD. 1995. Time to Hit HIV, Early and Hard. N Engl J Med, 333:450-451.

Khairandish P, Mohraz, M, Farzamfar B, Abdollahi M, Shahhosseiny M.H, Madani H, Sadeghi B, Heshmat R, Gharibdoust F, Khorram-Khorshid HR. 2009. Preclinical and phase 1 clinical safety of Setarud (IMOD), a novel immunomodulator. DARU J, 17:148-156.

Khorram Khorshid HR, Novitsky YA, Abdollahi M .2008. Studies on potential mutagenic and genotoxic activity of Setarud. DARU J, 16:223-228.

Khorshid H, Azonov J, Novitsky Y, Farzamfar B, Shahhosseiny M. 2008. Hepatoprotective effects of setarud against carbon tetrachloride-induced liver injury in rats. Indian J Gastroenterol, 27:110-2.

Lederman MM. 2001. Immune restoration and CD4+ T-cell function with antiretroviral therapies. AIDS, 15:S11-S15.

Li TS, Tubiana R, Katlama C, Calvez V, Mohand HA, Autran B .1998. Long-lasting recovery in CD4 T-cell function and viral-load reduction after highly active antiretroviral therapy in advanced HIV-1 disease. Lancet, 351:1682-1686.

Lucas GM .2005. Antiretroviral adherence, drug resistance, viral fitness and HIV disease progression: a tangled web is woven. J Antimicrob Chemother, 55:413-416.

Lutwama F, Serwadda R, Mayanja-Kizza H, Shihab HM, Ronald A, Kamya MR, et al., .2008. Evaluation of Dynabeads and Cytospheres Compared With Flow Cytometry to Enumerate CD4+ T Cells in HIV-Infected Ugandans on Antiretroviral Therapy. J Acquir Immune Defic Syndr, 48:297-303.

MacLennan CA, Liu MK, White SA, van Oosterhout JJ, Simukonda F, Bwanali J, Moore MJ, Zijlstra EE, Drayson MT, Molyneux ME. 2007. Diagnostic accuracy and clinical utility of a simplified low cost method of counting CD4 cells with flow cytometry in Malawi: diagnostic accuracy study. BMJ, 335:190-190.

Malta M, Strathdee SA, Magnanini MMF, Bastos FI. 2008. Adherence to antiretroviral therapy for human immunodeficiency virus/acquired immune deficiency syndrome among drug users: a systematic review. Addiction, 103:1242-1257.

May MT, Ingle SM .2011. Life expectancy of HIV-positive adults: a review. Sex Health, 8:526-533.

Mellors JW, Munoz A, Giorgi JV, Margolick JB, Tassoni CJ, Gupta P, Kingsley LA, Todd JA, Saah AJ, Detels R, Phair JP, Rinaldo CR Jr. 1997. Plasma Viral Load and CD4+ Lymphocytes as Prognostic Markers of HIV-1 Infection. Ann Intern Med, 126:946-954.

Mohraz M, Khairandish P, Kazerooni PA, Davarpanah M.A, Shahhosseiny M. H, Mahdavian B, Vaziry S, Shahriary S, Kamali K, Khorram Khorshid HR, Heshmat R, Farhadi M, Gharibdoust F. 2009. A clinical trial on the efficacy of IMOD in AIDS patients. DARU J, 17:277-284.

Mohraz M, Sedaghat A, SeyedAlinaghi Sasheri H, Mohammaddoust S, Gharibdoost F, Khorram Khorshid HR, Farhadi M, Madani SH, Kamali k. 2013. Post Marketing Surveillance on Safety and Efficacy of IMOD in Iranian Patients with HIV/AIDS. Infect Disord Drug Targets, 13:71-74.

Montessori V, Press N, Harris M, Akagi L, Montaner JSG .2004. Adverse effects of antiretroviral therapy for HIV infection. CMAJ, 170:229-238.

Murphy RA, Sunpath H, Kuritzkes DR, Venter F, Gandhi RT. 2007. Antiretroviral Therapy—Associated Toxicities in the Resource-Poor World: The Challenge of a Limited Formulary. J Infect Dis, 196:449-456.

Mwamburi D, Ghosh M, Fauntleroy J, Gorbach S, Wanke C. 2005. Predicting CD4 count using total lymphocyte count: a sustainable tool for clinical decisions during HAART use. Am J Trop Med Hyg, 73:5862.

Nachega J, Marconi V, van Zyl G, Gardner E, Preiser W, Hong S. 2011. HIV treatment adherence, drug resistance, virologic failure: evolving concepts. Infect Disord Drug Targets, 11:167-74.

Nachega JB, Mills EJ, Schechter M. 2010. Antiretroviral therapy adherence and retention in care in middle-income and low-income countries: current status of knowledge and research priorities. Curr Opin HIV AIDS, 5:70-77.

Orrell C .2005. Antiretroviral adherence in a resource-poor setting. Curr HIV/AIDS Rep, 2:171-176.

Orsi F, d'Almeida C .2010. Soaring antiretroviral prices, TRIPS and TRIPS flexibilities: a burning issue for antiretroviral treatment scale-up in developing countries. Curr Opin HIV AIDS,5:237-24.

Paydary K, Emamzadeh-Fard S, Khorram Khorshid H, Kamali K, SeyedAlinaghi S, Mohraz M .2012. Safety and efficacy of Setarud (IMOD TM ) among people living with HIV/AIDS: a review. Recent Pat Antiinfect Drug Discov, 7:66-72.

Roca B, Gómez CJ, Arnedo A .1999. Stavudine, lamivudine and indinavir in drug abusing and non-drug abusing HIV-infected patients: Adherence, side effects and efficacy. J Infect, 39:141-145.

Sax PE, Baden LR .2009. When to Start Antiretroviral Therapy — Ready When You Are? N Engl J Med, 360:1897-1899.

Schreibman T, Friedland G .2004. Use of Total Lymphocyte Count for Monitoring Response to Antiretroviral Therapy. Clin Infect Dis,38:257-62.

Schwartländer B, Stover J, Walker N, Bollinger L, Gutierrez JP, McGreevey W, et al. 2001. Resource Needs for HIV/AIDS. Science, 292:2434-2436.

SeyedAlinaghi S, Paydary K, Emamzadeh-Fard S, Mohraz M .2012. Treatment with IMODTM as a Novel Immune Modulator in HIV Positive Patients. J AIDS Clinic Res, 3:1000180 .

Siegfried N, Uthman O, Rutherford G .2010. Optimal time for initiation of antiretroviral therapy in asymptomatic, HIV-infected, treatment-naive adults. Cochrane Database Syst Rev, 17:1-29.

Spencer RC .2000. Mandell, Douglas and Bennett's Principles and Practice of Infectious Disease 5th Edn (two volumes). J Antimicrob Chemother, 46.

Vogel M, Schwarze-Zander C, Wasmuth J-C, Spengler U, Sauerbruch T, Rockstroh JK .2010. The Treatment of Patients with HIV. Dtsch Arztebl Int, 107:507-516.

Zabihollahi R, Namazi R, Aghasadeghi MR, Esfahani AF, Sadat SM, Modarressi MH. 2012. The in vitro anti-viral potential of Setarud (IMOD™), a commercial herbal medicine with protective activity against acquired immune deficiency syndrome in clinical trials. Indian J Pharmacol, 44:448-453.