CTN 257: Impact of HIV on mucosa

About the Study

This study will assess the impact of HIV infection and antiretroviral therapy on mucosal (gut) and systemic memory CD4 T cells in treatment-naïve HIV-positive individuals within six months of infection. Researchers believe this study will generate data to better understand how HIV harms the body and how they can use this information to better design HIV therapies and vaccines in the future.

The study does not require participants to take any medications and will only require the completion, with study personnel, of questionnaires and blood tests. Researchers will collect clinical, socio-demographic and behavioural data. Participants will also have the option to have up to three rectal biopsies performed during the study.

The questionnaire data, along with specific immune and viral findings obtained from circulating blood and mucosa samples, will be analyzed. Researchers hope to gain a better understanding of how HIV infection and antiretroviral therapy (ART) affects immune activation and disease progression.

Background

During early infection with HIV, a large number of cells that help fight off infections by viruses are destroyed, both in the blood as well as in the gut. These cells found in the gut make up GALT — gut associated lymphoid tissue – and has been found to play a critical role in the early pathogenesis of HIV infection. Researchers think it is important to study samples of the gut because GALT represents a large site of HIV replication. Even after treatment with ART, only a partial restoration of these cells in the gut is observed. Researchers will assess the impact of HIV on these cells during early HIV infection, and how this contributes to HIV disease progression.

Study Approach

To safely gather a tissue sample from the gut of a participating individual, a certified gastroenterologist will perform up to three recto-sigmoid biopsies, all of which are optional: at study baseline, before ART initiation and after 48 weeks of treatment.