Trial to Evaluate Long-Acting Injectables for People Struggling to Adhere to Daily Oral ART

Adherence to antiretroviral therapy (ART) is paramount to igniting and maintaining virologic suppression in individuals living with HIV. Despite this, some people struggle with adhering to a daily ART regimen and thereby struggle to achieve and maintain suppression.

Long-acting injectables may be a solution to this difficult problem, as the treatment replaces the burden of taking a pill daily with the option of receiving an injection once a month. Monthly injections were well-tolerated and well-received by volunteers enrolled in both the FLAIR and ATLAS trials.

“Adhering to daily medication remains a major health care challenge for patients with chronic health conditions,” Jose Castillo-Mancilla, MD, associate professor of medicine at the University of Colorado School of Medicine, and protocol co-chair of LATITUDE, said in a press release. “The generous volunteers who enroll in this study will help to ensure that more people living with HIV may have effective treatment regimens that work for them.”

Now, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has announced the Long-Acting Therapy to Improve Treatment Success in Daily Life, or LATITUDE, clinical trial.

LATITUDE will evaluate long-acting ART for maintaining HIV suppression in individuals who struggle to take daily oral ART. Specifically, the study will assess whether a combination of 2 long-acting injectable formulations of cabotegravir/rilpivirine (CAB/RPV) are superior to oral ART in managing HIV infections among this population.

The study will enroll 350 participants with documented treatment lapses within the past 18 months. The volunteers will begin a daily oral ART regimen with adherence and retention support. Participants who become virally suppressed by 24 weeks will be randomized to continue standard-of-care for 1 year or begin an oral regimen of CAB/RPV for 4 weeks, followed by oral injections every 4 weeks for 48 weeks.

Following the 52-week period, the participants in the standard-of-care arm may cross over to long-acting injectable arm and participants in the long-acting injectable arm may remain on the injectable therapy arm for an additional year.

During the study period, the investigators will monitor volunteers’ viral loads and other indicators of immune health to compare the effectiveness of the 2 treatments.

“Monthly injectable antiretroviral therapy may prove more convenient, discreet and appropriate for some people living with HIV,” Aadia Rana, MD, associate professor of medicine at the University of Alabama at Birmingham Center for AIDS Research and protocol co-chair of LATITUDE, said in the press release. “Our study aims to help people living with HIV and facing challenges with adherence find a treatment option that meets their health needs and fits into their lives, allowing them to experience the health benefits of becoming durably, virally suppressed.”

Long-acting injectable CAB/RPV is also being evaluated in the HPTN 083 and HPTN 084 studies.

LATITUDE is being conducted by the AIDS Clinical Trials Group (ACTG), with additional support from the National Institute of Mental Health, the National Institute on Drug Abuse, ViiV Healthcare and the Janssen Pharmaceutical Companies of Johnson & Johnson.