Study to monitor the adverse effects by different HAART regimens in HIV patients with tuberculosis

Radhey Shyam, Arpita Singh, Dheeraj Kumar Singh, Ajay Kumar Verma, Pratap Shankar, Sachin Tutu, Rakesh Kumar Dixit


Background: In the modern era, AIDS is not less than a disaster for the human race. More than two-third of HIV-infected individuals have an associated infectious pulmonary disease. Mycobacterium tuberculosis is more virulent than most of other opportunistic pathogen causing latent infection. HIV is characterized by a profound immunodeficiency resulting from a progressive, quantitative and qualitative deficiency of the subset of CD4 T lymphocytes referred to as helper T cells leading to the patient at high risk of developing a variety of opportunistic infections. At present AIDS is incurable but some of the drugs have shown to decrease the mortality and morbidity of the disease. These are called as Highly Active Anti-Retroviral Therapy (HAART). However, these drugs are associated with a significant number of side effects. This work has been conducted in order to study the demographic profile of HIV patients with TB and monitor the adverse effects of different HAART regimens among them.

Methods: A total of 3078 patients screened for the study. Those who were diagnosed with HIV were enrolled. Pretreatment parameters like, CD4, CD8 + lymphocyte count and their ratio, haemogram etc. were recorded. Patients were divided into four groups and were started with different HAART regimens. They were monitored regularly for the appearance of any adverse effects.

Results: The prevalence of HIV sero-positivity was found to be 3.60%. Out of them, 71.18% were males and 28.82% were females. The highest prevalence (43.29%) was in the age group of 21-50 years. The sero-positive rate was found more in married males as compared to married females and unmarried cases. Side effects were present in all the groups. The most common side effect was GI intolerance and was most frequent in Group I. Anemia and neutropenia occurred in the Zidovudine containing groups (group I, III and IV). Peripheral neuropathy occurred most commonly in cases of Group II. Rashes occurred in nevirapine containing groups. Liver function derangement was noticed more in group I and II. 71.4% of patients on HAART regimen showed improvement in symptoms while 28.57% did not show any improvement.

Conclusions: The prevalence of HIV sero-positivity in our study was 3.60%. The rate of sero-positivity was more in males as compared to females while it was highest in the individuals of 21-50 years of age. The most common side effect was GI intolerance and was most frequent in Group I. Anemia and neutropenia occurred most frequently in Zidovudine containing groups. Peripheral neuropathy occurred most commonly in cases of Group II (Stavudine + Lamivudine + Nevirapine). Deranged lipid profile was found to occur due to indinavir in patients of Group IV. After starting on HAART regimens, 74.4% showed significant improvement in symptoms.


Antiretroviral regimens, AIDS, CD4 count, HAART, Seropositive

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AIDS 2002: Antiretroviral Therapy guidelines. File Format PDF, Adobe Acrobat- View as HTML from the Internet at New Mexico AIDS Infonet Fact Sheet Number 411 2002 ANTIRETROVIRAL THERAPY GUIDELINES

Arora VK, Seethaaraman ML, Gowrinath K, Rao SR. lung and HIV infectio with special reference to tuberculosis Indian Chest Dis. Allied Science. 1993;35(3):103-12.

Dhurat R, Manglanu M, Sharma R, Shah NK. Clinical spectrum of HIV infection Indian Pediatr. 2000 Aug;37(8):831-6.

Merchant RH, Oswal JS, Bhagwat RV, Karkare J. clinical profile of HIV infection Indian Pediatr. 2001 Mar;38(3):239-46.

Oka S. current HIV therapy and its clinical problems. Rinsho Byori. 2000 Jul;48(7):575-9.

Mehta U. Pharmacovigilance: the devastating consequences of not thinking about adverse drug reactions. Contin Med Educ. 2011;29(6):247-2251.

Shubber Z, Calmy A, Andrieux-Meyer I, Vitoria M, Renaud Thery F, Shaffer N, et al. Adverse events associated with nevirapine and efavirenz-based first-line antiretroviral therapy: a systematic review and meta-analysis. AIDS. 2013;27:1403-12.

Reddenna L, Basha SA, Gopal DV, Krishna TR. Highly Active antiretroviral Therapy: Incidence of Adverse Drug Reactions. International Journal of Allied Medicinal Sciences and Clinical Research. 2013(1):25-30.

Srikanth AB, Babu SC, Yadav HN, SK J. Incidence of adverse drug reactions in human immune deficiency virus-positive patients using highly active antiretroviral therapy. J Adv Pharm Technol Res. 2012;3:62-7.

Luma NH, Doualla MS, Choukem SP, Temfack E, Ashuntantang G, Joko HA, et al. Adverse drug reactions of Highly Active Antiretroviral Therapy (HAART) in HIV infected patients at the General Hospital, Douala, Cameroon: A cross sectional study. Pan Afr Med J. 2012;12:87.

Eluwa GI, Badru T, Akpoigbe KJ. Adverse drug reactions to antiretroviral therapy (ARVs): incidence, type and risk factors in Nigeria. BMC Cen Clin Pharmacol. 2012;12:7.

Sivaraman V, Fernandez G, Rao SR. HIV infection in pulmonary TB. Report of six cases. Ind J Tuber. 1992;39:35-9.

Arora VK, Gowrinath K, Rao S. Extrapulmonary involvement in HIV with special reference to tuberculosis cases. Ind J Tub. 1995;42:27.

Mohanty KC, Basheer PMM. Changing trend of HIV infection and tuberculosis in a Bombay area since 1988. Indian J Tuberc. 1995;42:117-20.