Rutgers New Jersey Medical School (NJMS) Research with a Heart is looking for people to participate in two studies assessing the effectiveness of an HIV prevention medication.
Shobha Swaminathan, associate professor of medicine at NJMS and principal investigator for the studies, said the aim of this research is to expand the options for HIV prevention medicine in order to increase access to such treatments.
“We currently only have one pill ... to prevent HIV infection among cisgender women, which needs to be taken every single day,” she said. “For men who have sex with men and transgender women, we have two medications that are approved to prevent HIV infection, but they both require one pill every single day, which can be quite challenging.”
Despite the availability of these medications, Swaminathan said, there continue to be new infections, which is why researchers have been trying to develop new, safe medications to prevent HIV infections among high-risk populations.
Impower 022 and Impower 024 will study the medication Islatravir, given orally via pill, in order to evaluate its effectiveness in preventing HIV infection in transgender women, high-risk cisgender women and cisgender men who have sex with men, Swaminathan said.
As part of a new class of HIV treatment drugs called nucleoside reverse transcriptase translocation inhibitors, the tablet is the first of its kind and only needs to be administered once a month due to its lengthy half-life, she said.
Swaminathan said that the studies will compare the effects of Islatravir taken once a month with those of the currently available medications, which are taken once daily. The studies are placebo-controlled, she said, which means that neither the participants nor the researchers will be aware of which medication each participant is receiving.
Participants will be examined at least once a month for the duration of the studies, which are estimated to last approximately two to three years, depending on when certain study endpoints are met, she said. Impower 022 and Impower 024 will be conducted around the same time next year on Feb. 24, 2022 and March 15, 2022 respectively.
Swaminathan said medications that await approval should be representative of the population they will ultimately benefit, meaning there needs to be a diverse representation of communities in clinical trials. The Impower studies include participants from the Newark area as well as individuals from further away.
“Essex and Hudson counties are 2 of 48 counties recognized by the federal government as having high need for HIV treatment and prevention options (due to) the increased cases in these areas,” she said. “We have limited options for HIV prevention — we basically have just one pill for women and two pills for men — so clearly, not enough.”
Swaminathan said that multiple options are also in high demand because certain populations, such as people who are homeless, people with mental health conditions and people with unstable housing, may not be able to consistently take the current medications once a day.
“It’s ultimately about giving people choices,” she said. “We want to be able to offer our community access to cutting-edge science and clinical trials that are available globally.”