The criteria described in this manuscript enabled rapid and efficient ART initiation across a diverse network of thirty participating clinical research sites in six countries.
MHRP researcher Dr. Trevor Crowell was lead author of a recent paper, “Novel Criteria for Diagnosing Acute and Early HIV Infection in a Multi-National Study of Early Antiretroviral Therapy Initiation,” in Clinical Infectious Diseases.
Antiretroviral therapy (ART) initiation during acute and early HIV infection (AEHI) limits HIV reservoir formation and may facilitate post-ART control. However, very early diagnosis can be logistically challenging and is therefore mostly limited to research settings. Diagnosis is complicated by the fact that AEHI may cause no or non-specific symptoms.
The study found that six laboratory-based assay criteria for acute and early HIV infection can be used to support HIV diagnosis in early stages of infection, establish relative recency of infection, accommodate a variety of available testing procedures, and estimate stage of infection in diverse clinical and research settings.
“Importantly, several criteria did not include a requirement for viral load testing before ART initiation, which can delay confirmation of HIV diagnosis particularly in resource-limited settings,” said Crowell, who was co-chair of the AIDS Clinical Trials Group (ACTG) study.
ACTG is an NIH-funded network of experienced clinical research centers. It enrolled 195 adults at 30 sites in the Americas, Africa and Asia who met any one of six criteria based on combinations of results. These criteria will be used in several upcoming studies that seek to enroll participants with acute and early HIV infection in order to evaluate the safety and efficacy of novel treatments for HIV.
There may be barriers to utilizing these criteria in other settings, including resource-limited settings and routine clinical care centers. However, as the testing modalities used for the study become more commonplace, implementation of these criteria should become easier.
Publication details: . 2020 Dec 31;ciaa1893. doi: 10.1093/cid/ciaa1893.