NIH trial evaluates long-acting HIV medication in place of strict daily regimens

Research sites across the U.S. have begun conducting a clinical trial to evaluate long-acting antiretroviral therapy (ART) for maintaining HIV suppression in people who have trouble adhering to conventional daily oral ART. The study, funded by the National Institutes of Health, is called Long-Acting Therapy to Improve Treatment Success in Daily Life, or LATITUDE and is designed to determine whether a combination of two experimental injectable formulations of ART are superior to conventional oral ART in managing HIV infection in this population.

Up to a quarter of people prescribed conventional ART stop taking the medication for some period. Not taking ART as prescribed is the most common reason people do not achieve durable viral suppression. Many complex factors such as access to healthcare, economic and housing insecurity and stigma may influence a person’s ability to adhere to a treatment regimen. Long-acting ART formulations may particularly benefit those who cannot or would prefer not to take medication each day or to not keep oral medications in their home or possession.

“Antiretroviral therapy has been transformative in the treatment of HIV. Consistently taking these medications as prescribed helps people to live longer, healthier lives and prevents HIV transmission to sexual partners,” said Anthony S. Fauci, Director of the National Institute of Allergy and Infectious Diseases, in the NIH statement. “Unfortunately, for many people who must take any medication regularly, adherence can be difficult.”

LATITUDE (also known as ACTG 5359) will test two experimental, long-acting injections of the antiretroviral drugs rilpivirine (RPV) and cabotegravir (CAB), which will be administered every 4 weeks by a healthcare professional in a research clinic. Throughout the study, investigators will evaluate volunteers’ viral load - the measure of virus in the blood - and other indicators of immune health to compare the treatment’s effectiveness to that of conventional oral ART.

“Monthly injectable antiretroviral therapy may prove more convenient, discreet and appropriate for some people living with HIV,” said Aadia Rana, M.D., associate professor of medicine at the University of Alabama at Birmingham Center for AIDS Research and protocol co-chair of LATITUDE.

LATITUDE will enroll approximately 350 volunteers with documented treatment lapses within the past 18 months. All study participants will begin a daily oral ART regimen and individualized adherence and retention support.

Volunteers who become virally suppressed by week 24 will then be randomized to either continue standard-of-care therapy for one year or begin an oral regimen consisting of RPV and CAB for 4 weeks, followed by long-acting injectable formulations of those drugs every 4 weeks for 48 weeks.

After this 52-week period, participants originally randomized to the standard-of-care arm may cross over to long-acting therapy, and participants originally randomized to the long-acting therapy arm may remain on that regimen for an additional year.