THE OBJECTIVE OF THIS CONTRACT IS TO ADAPT THE IPDA FOR THE MEASUREMENT OF LATENT HIV-1 FOR INDIVIDUALS WITH HIV-1 VIRAL GENETIC SUBTYPE CRF-1_AE.

Human immunodeficiency virus type-1 (HIV-1) is a retrovirus that infects CD4+ T cells of the immune system. If left untreated, HIV-1 infected individuals will progress to AIDS and may ultimately die as a result. Current antiretroviral therapy is able to suppress HIV-1 replication, but it does not cure the infection. This is because HIV-1 persists in a stable and quiescent DNA form integrated into the genomes of CD4+ T cells. This persistent HIV-1 is called the latent reservoir and it is considered the barrier to curing the infection. Developing new therapies that can reduce or eliminate the HIV-1 latent reservoir and ultimately cure the infection is a global scientific priority. To support this effort, clinical tests are needed that can accurately measure the HIV-1 latent reservoir in the blood or tissues of people with HIV-1. This SBIR Phase I Contract proposal aims to further the development of a new sequence-based assay for the HIV-1 latent reservoir known as the Intact Proviral DNA Assay (IPDA). In this proposal, we aim adapt the IPDA to cover additional genetic subtypes of HIV-1 based on expanded in-depth sequencing of the HIV-1 latent reservoir, then test the performance of the adapted IPDA.