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A Focus on Acute Infection Studies
The study of acute HIV infection is critical to the design and development of HIV vaccines and strategies to achieve an undetectable level of virus without antiretrovirals, or a functional cure. By diagnosing HIV within weeks or even days of infection, scientists are afforded the opportunity to study the early events following infection. This provides the opportunity to look at what the virus and the cells are doing at various places in the body and identify ways to intervene.
MHRP is conducting two unique studies that are enrolling patients within weeks of HIV infection: RV217, the Early Capture HIV Cohort (ECHO) study and RV254/SEARCH 010. Both studies are enrolling in Thailand and RV217 is also underway at multiple sites in east Africa.
An observational study taking place at four sites, RV217 is designed to characterize recruitment, retention, HIV prevalence, HIV incidence and biological characteristics of acute HIV infection in high-risk volunteers such as sex workers and MSM. The study also seeks to provide a unique set of biological specimens including blood and mucosa. In this unprecedented study, researchers collect very small blood samples twice weekly via finger stick collections. These “small blood volume” visits allow clinicians the opportunity to diagnose HIV infection prior to the advent of detectable antibody by the most sensitive nucleic acid detection techniques available. RV217 has screened more than 3,600 individuals and identi!ed 95 acute HIV infections.
RV254—a collaboration between MHRP and the South East Asia Research Collaboration with Hawaii (SEARCH)—is a similar cohort to RV217, but is also comparing early initiation of HAART to megaHAART. Although no dierence in outcome has been seen between the different therapies, researchers have noted that patients who start ART during acute HIV infection have, at one year, levels of virus similar to that of elite controllers, or the small percentage of people who can naturally control the HIV virus. Furthermore, the earlier patients start treatment the less integrated HIV DNA they have in their central memory CD4+ T cells, which historically has been a major barrier to curing HIV.
To date, RV254 has screened nearly 88,000 people and identified 158 acute HIV infections. Confirmation of acute infection to enrollment into the study occurs within three days and treatment is initiated within two days following enrollment. The majority of RV254 participants were enrolled within 2-3 weeks of infection.
While researchers believe that early diagnosis and immediate treatment are the stepping stones to a functional cure, more research is needed to better understand the adaptive, innate and host responses that alter viral load set-point and consequently prognosis and infectiousness.