“A randomized controlled single blind clinical trial to evaluate effectiveness of empirical treatment with albendazole in delaying disease progression among human immunodeficiency virus positive antiretroviral therapy naïve patients at an antiretroviral therapy center of a tertiary care hospital”

Abstract

Introduction: Parasitic opportunistic infections are widely accepted to accelerate the progression of human immunodeficiency virus (HIV) infection to acquired immunodeficiency syndrome. A large number of interventions are needed to delay HIV progression and improve the health status of HIV patients. The cheapest, simplistic, and practical intervention in a resource-limited setting like India, where HIV and helminth co-infection is common, is deworming. Methodology: The participants were assesses for their eligibility and recruited into two study arms. Both groups were followed for 1 year. CD4 count was assessed at baseline, 6 months, and 12 months. Study participants assigned to the treatment group were treated at 0, 3, 6, and 9 months with tablet Albendazole (400 mg) for 3 days. Study participants assigned to the control arm were given Placebo (Tablet Calcium 500 mg) for 3 days at 0, 3, 6, and 9 months. Results: In both treatment group and the placebo control group, the mean CD4 count was found to be declining. The mean decline in CD4 count of the intervention group was 72 cells/mm3 at 6 months and 85 cells/mm3 at 1 year. Similarly, the mean decline of CD4 count in the control group was 94 cells/mm3 at 6 months and 120 cells/mm3 at 1 year. We found that the mean difference in CD4 count between the intervention group and control group was −31.66 cells/mm3, −9.98 cells/mm3 and 24.87 cells/mm3 at baseline, 6 months, and 1 year, respectively. Our results are consistent with various other studies conducted in Uganda and Africa, as well as Cochrane systematic review. Conclusion: We conclude that empirical treatment with Albendazole in HIV-positive antiretroviral therapy naïve patients has no significant influence on delaying the progression of HIV disease.

Keywords

• helminths
• human immunodeficiency virus
• human immunodeficiency virus helminthic co-infection
• randomized controlled trial