New clinical trial to assess antiretroviral treatment in HIV-infected individuals based on CD4 counts

March 02, 2016

Participants will be followed for up to five years. Once enrolled, they will return to the clinic to be seen by study staff at one month, four months and then every four months thereafter. At each visit, participants will provide a medical update and undergo a brief medical exam, and CD4 cell counts and viral load (the amount of HIV in the blood) will be recorded.

The study is being conducted by the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT), an HIV/AIDS clinical trial network funded by NIAID. The University of Minnesota in Minneapolis is the trial sponsor with primary funding from NIAID and additional funding provided by other NIH entities, including the National Cancer Institute, the National Heart, Lung and Blood Institute, the National Institute of Mental Health, the National Institute of Neurological Disorders and Stroke, and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Additional support comes from four government organizations based in Australia, France, Germany, and the United Kingdom.

Although START will primarily look at major health outcomes associated with immediate and deferred antiretroviral therapy, the study will also examine HIV transmission risk behaviors, treatment adherence, drug resistance, health care utilization and the cost of care. "The intent is to fully evaluate the individual and the broader public health implications of earlier antiretroviral treatment," according to James D. Neaton, Ph.D., of the University of Minnesota, principal investigator for INSIGHT.

START will also feature several sub-studies to be conducted across some of the 200 study sites. These sub-studies include examining the effect of genetic variants of the virus on the progression of untreated HIV, as well as the response of patients to antiretroviral therapy; comparing the early and deferred antiretroviral groups for neurocognitive function and measures of vascular function, pulmonary function, and bone mineral density; and evaluating participant understanding of study information and satisfaction with the consent process to better inform future research guidelines.

Source: NIH/National Institute of Allergy and Infectious Diseases