Temple University Hospital Part of International Study that Revealed HIV Therapy Should Start at Diagnosis

Temple University Hospital took part in a major international, randomized clinical trial which found that HIV-infected individuals have a considerably lower risk of developing AIDS or other serious illnesses if they start taking antiretroviral drugs immediately upon diagnosis rather than later.

“This study answered the question everyone always had,” said Ellen M. Tedaldi, MD, local principal investigator of the trial and HIV Director at Temple University Hospital. “The study proved that starting therapy early reduced progression of HIV and prevented other non-AIDs related events, like major cardiovascular disease and renal cancer. The study showed that the risk of developing serious illness or death was reduced by 53 percent.”

For many years clinicians believed the risks of early therapy possibly outweighed the benefits of taking the antiretroviral drug sooner, Tedaldi notes. But, with the study’s new findings, she says it is a major shift in the approach to HIV therapeutics.

The Strategic Timing of AntiRetroviral Treatment (START) study randomly assigned participants either to begin antiretroviral treatment immediately or delay starting treatment until their CD4+ T-cells dropped to 350 cells per cubic millimeter, which Dr. Tedaldi says is the ordinary guideline for when doctors start HIV therapy.

The START clinical trial began in 2009 and was expected to end in December 2016. However, Dr. Tedaldi says the results of the study were released early because the data and safety monitoring board (DSMB) found compelling evidence that starting the antiretroviral treatment immediately outweigh the risks. “We now have confirmation that it is important to diagnose people and start therapy right away.”

Temple University Hospital was one of 215 sites participating in the trial worldwide and enrolled ten HIV-infected patients, ages 18 years or older. Dr. Tedaldi says participants in the trial will continue to be monitored through 2016 and that any patient not on HIV therapy and not already taking part in the study will be offered the opportunity to start treatment as soon as possible.