Trial to compare injection to daily pills for HIV prevention
The University of Illinois at Chicago will begin recruiting participants for a clinical trial to compare the efficacy of a newly-developed injectable drug to prevent new infections of the HIV virus with Truvada, the only FDA-approved drug currently available to prevent the spread of HIV.
Truvada, approved in 2012, is a pill that is taken every day to prevent becoming infected with HIV, said Dr. Richard Novak, the Harry F. Dowling Professor and chief of infectious disease in the UIC College of Medicine and principal investigator on the grant. “The number one reason that Truvada fails to prevent the transmission of HIV is when it’s not taken consistently every day as prescribed,” Novak said.
Truvada is known as a PrEP, or pre-exposure prophylaxis. It is meant to be taken by populations at an increased risk for acquiring HIV, including men who have sex with men. With regular condom use, Truvada can significantly decrease the risk of becoming infected with HIV. However, adherence can be a problem for some.
Cabotegravir is an injectable pre-exposure prophylaxis administered once every two months. “If people only need to get a shot once every two months instead of having to remember to take pills every day, we think that the rate of transmission among those on the injectable will decrease,” Novak said.
To determine the efficacy of cabotegravir compared to Truvada, Novak and colleagues will be recruiting participants to the HPTN 083 study, a multi-national trial that will enroll approximately 4,500 HIV-uninfected men who have sex with men and transgender women at risk for acquiring HIV infection, ages 18 or older at sites in the Americas, Asia and South Africa. Novak hopes to enroll approximately 60 patients in Chicago.
At UIC, the trial will be conducted by Project WISH, the clinical trials research arm of the UIC College of Medicine’s division of infectious disease. The trial is funded by the National Institutes of Health and is part of their HIV Prevention Trials Network.
Participants will be randomly assigned to one of two clinical treatment arms each with three distinct steps that collectively can last up to four and a half years. Participants who acquire HIV will be discontinued from the study medication and referred for HIV care.
Throughout the clinical trial, participants will be on one of the HIV prophylaxis medications at all times. In step one, participants are assigned to receive either oral cabotegravir or Truvada as pills taken daily in addition to a placebo pill for five weeks. In step two, participants receive either cabotegravir injections two times four weeks apart and once every eight weeks thereafter plus a daily placebo pill, or Truvada taken daily and a placebo injection two times four weeks apart and once every eight weeks thereafter. Step two will last 182 weeks. In step three, both groups of participants will take Truvada every day for 48 weeks.
“If the trial is successful, Cabotegravir may have a huge impact in curtailing HIV transmission in the future,” said Novak. “New HIV infections among men who have sex with men and transgender women who have sex with men is on the rise, and new drugs are needed to more effectively block transmission.”
UIC’s Project WISH has initially received up to $1.8 million dollars to enroll patients in the clinical trial from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. Project WISH may receive additional funds depending on the number of participants enrolled.
Dr. Stockton Mayer and Dr. Max Brito in the UIC College of Medicine are coinvestigators on the study. John Stryker and Anthony Johnson from UIC are also on the grant.
For more information on HPTN 083, visit projectwish.uic.edu