Abstract:

The outcome of HIV infection is different between men and women, in part due to the influence of sex hormones. Sex hormones not only influence the immune response but also regulate HIV replication and HIV latent reservoir. To the best of our understanding, this is the first study in India to investigate the influence of sex dichotomy and sex hormones on immune activation (IA), immune checkpoint (IC) markers and their interplay and outcome on HIV reservoir. This will be studied by determining the level of chronic inflammation, IA and phenotypic characteristics of immune subsets in Highly Active Antiretroviral Therapy (HAART) suppressed men and women and by correlating the size of reservoir in men and women by level of IA and IC markers and sex hormones. To achieve this, 50 HIV-ve and 400 HIV+ve ART naïve participants will be enrolled at the time of ART initiation and followed till 12 months for identifying virological suppression (VS). The VS participants will be assessed for IA and IC markers and participants with highest and lowest IA and IC markers will be studied for HIV-1 latent reservoir and compared between men and women. Further sex hormones will also be studied to identify its role in HIV latency. Through this study, we can understand the influence of hormones on HIV-1 mediated IA between sexes. Also we will possibly be able to identify the correlation between IA and reservoir size in VS participants. This study will pave the way for using hormones as latency reversal agents.