Dapivirine vaginal ring and tablets of oral PrEP medication (National Institute of Allergy and Infectious Diseases, NIH)
8 Feb. 2019. A clinical trial is underway testing use and preferences for drugs or a medical device to prevent HIV infection among young women and teenage girls in Africa. The trial, aiming for a highly vulnerable population for HIV infection in Africa, is conducted by Microbicide Trials Network in Pittsburgh, and funded by National Institute of Allergy and Infectious Diseases, or NIAID, and other institutes at National Institutes of Health.
According to Microbicide Trials Network, some 1,000 girls and young women age 15 to 24 in Africa are likely to become infected with HIV, with AIDS that can develop from HIV infection already the leading cause of death in this population. The group cites data from the UN agency for HIV and AIDS showing women comprise 26 percent of new HIV infections in eastern and southern Africa, while making up only 10 percent of the population.
The trial known as Reversing the Epidemic in Africa with Choices in HIV prevention, or Reach, is testing 2 complementary methods for preventing HIV infection among African women and girls, which Microbicide Trials Network says enrolled its first participant. The mid-stage clinical trial is recruiting 300 women and girls, age 16 to 21 in Uganda and Zimbabwe, but expanding to Kenya and South Africa.
All participants will receive a vaginal ring containing the drug dapivirine, a non-nucleoside reverse transcriptase inhibitor that prevents HIV viruses from replicating inside healthy cells. Dapivirine vaginal rings work for 1 month releasing the drug in the vagina. The treatments are currently in review by the European Medicines Agency. Participants will also receive a daily tablet called Truvada, made by Gilead Sciences. Truvada is a combination of the anti-HIV drugs tenofovir and emtricitabine, a method known as pre-exposure prophylaxis or PrEP. Earlier trials show both techniques are effective in women, but not always followed sufficiently among teenage girls.
In the Reach trial participants are randomly assigned to first use the dapivirine ring for 6 months, followed by taking a daily Truvada pill for 6 months, or start with Truvada for 6 months, followed by using the vaginal ring for 6 months. Gilead Sciences is providing Truvada for the trial, while the International Partnership for Microbicides is providing the dapivirine ring. Participants are followed for 18 months after enrollment.
The Microbicide Trials Network team is looking primarily for signs of moderate or severe adverse effects from the treatments, as well as measures of detectable levels of drugs in participants’ blood and residual drug levels in returned vaginal rings during the 6 month test periods. The study team is also evaluating participants’ reactions to and preferences for the drugs or vaginal rings during this period, as well as detectable and residual drug levels in blood and vaginal rings after 18 months.
“With PrEP being made available in many countries and the possibility that the ring will be approved,” says Lulu Nair, protocol chair for the Reach study in a Microbicide Trials Network statement, “we want to see that these products can work for and be made available to women and girls of all ages at risk of HIV acquisition, who both need and deserve methods of protection that are in their control.” Nair is clinical research site leader at the Desmond Tutu HIV Centre at University of Cape Town in South Africa. Results of the trial are expected in late 2022 or 2023.
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