Researchers at the University of Washington will test a pill once a month to prevent HIV in women thanks to a new $ 122 million grant from the Bill and Melinda Gates Foundation.
The grant is one of the first to emerge from the Gates Foundation since Bill and Melinda French Gates announced their divorce in May and days after Warren Buffett resigned as the organization’s only other director. The research is consistent with French Gates’ focus on women and girls.
The randomized phase 3 trial will compare the effectiveness of monthly islatravir, a pill in development by Merck, with a standard daily pill that prevents HIV-1.
The daily pill is already approved for the prevention of HIV, an approach called pre-exposure prophylaxis.
The study will involve 4,500 healthy, HIV-uninfected women at 21 sites in Africa and 500 women in the United States Young women in Africa account for about 25% of new HIV infections worldwide.
A monthly pill offers the possibility of improved ease of use and adherence. “The whole field is moving towards strategies that are less adherence dependent and easier for users of HIV prevention,” said Connie Celum, principal investigator of the study and professor of global health at UW, in one declaration.
Taking a daily pill can also raise barriers in populations where sexual activity is stigmatized. A study last year by Celum Jared Baeten, also professor of global health at UW, found that young African women had some of the biggest doubts about pre-exposure prophylaxis, citing issues such as discreet storage of products .
“If you were to only take a small pill once a month and not mind the daily intake and storage of the pills, it’s a whole different ball game,” Celum said.
To assess the effectiveness of islatravir, the researchers landed on a “double blind, double dummy” trial design. Participants will be given one of two treatments: a daily pre-exposure prophylaxis pill and a monthly placebo that looks like islatravir, or a daily placebo and a monthly dose of islatravir. The researchers will compare the HIV infection rate of women in the two test arms.
The new study has started recruiting from the United States and will begin screening subjects in Africa this month.
The Gates Foundation has awarded more than $ 3 billion in grants for HIV to date and nearly $ 3 billion to the Global Fund to Fight AIDS, Tuberculosis and Malaria.