A phase 2a trial evaluating the safety of and adherence to vaginal matrix ring (VR) containing dapivirine and oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) for pre-exposure prophylaxis (PrEP) is now underway, the National Institutes of Health has announced
The trial is designed to examine the safety of oral PrEP and a vaginal ring option in adolescent girls and young women in southern Africa. Investigators are hopeful that the study will provide information that will lead to safe, effective, and desirable choices of HIV prevention methods for women who are disproportionately affected by the HIV epidemic.
The phase 2a clinical trial is called REACH (Reversing the Epidemic in Africa With Choices in HIV Prevention) and is also referred to as MTN-034. REACH is a randomized, crossover, open-label study that will enroll 300 adolescent girls and young women aged 16 to 21 years at 5 sites in Kenya, South Africa, Uganda, and Zimbabwe.
At enrollment, the participants will be randomized to 1 of 2 sequences of 1 vaginal ring containing 25 mg of dapivirine to be inserted monthly for 24 weeks and 1 200 mg FTC/300 mg TDF oral tablet taken daily for 24 weeks. Following completion of the randomized sequence of both study product use periods, participants will then select between the 2 study products to use in the final 24 weeks of the trial.
Participants will be able to choose either the oral tablet or the vaginal ring, or neither study product during the third 24-week period. The participants will be examined monthly by the investigators in check-ups that may include
behavioral assessments, counseling, and blood, urine, and pelvic sample collection. Following completion, the participants will be followed for approximately 76 weeks.
The primary purpose of the study is for investigators to collect safety and adherence data over the course of study product use. It is anticipated that this study will take approximately 12 months at each site to enroll the target sample size.
Currently, the World Health Organization
recommends that oral PrEP tablets be offered as a prevention option for people at risk of HIV infection. For this study, the tablets will be provided by Gilead Sciences, Inc.
The dapivirine vaginal ring is an investigational product that is being supplied by the International Partnership for Microbicides (IPM).
The vaginal ring has found to be well-tolerated and to reduce the risk of HIV infection by approximately 30% in African women—27% in the ASPIRE
study and 31% in The Ring Study
, respectively. Higher levels of protection were seen in women 21 and older who used the ring more regularly (the studies included women ages 18 to 45).
IPM, which developed the dapivirine ring, is in the process of seeking regulatory approval for the product. The ring is currently undergoing regulatory review by the European Medicines Agency.
REACH is co-funded by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver
National Institute of Child Health and Human Development, and the National Institute of Mental Health, all part of the National Institutes of Health.
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