WASHINGTON, Jan. 18 (UPI) -- Federal officials said Wednesday they have halted enrollment in a global HIV trial due to a higher risk in some patients.
The officials said the decision was made because patients in the study of HIV/AIDS therapies who were on episodic treatment were more likely to die.
The international trial, the Strategies for Management of Anti-Retroviral Therapy, or SMART, was comparing continuous antiretroviral therapy with episodic treatment initiated only when CD4 cells dropped below a certain threshold.
The National Institute of Allergy and Infectious Diseases, which was overseeing SMART, said the Data and Safety Monitoring Board recommended enrollment be halted after a review of interim data revealed that patients on episodic therapy were twice as likely to either die or develop clinical AIDS.
The episodic group also had an increase in major complications, including heart, kidney and liver diseases.
NIAID, part of the National Institutes of Health, said follow-up visits will continue for all SMART participants and it recommended that those in the episodic group be switched to continuous antiretroviral therapy.
