KIGALI - Project Ubuzima will spend the next three years conducting a research on an Anti-HIV gel for women following the approval by the Medical Ethics Committee.
The vaginal gel is part of the microbicide medical products and is believed to reduce the risk of HIV infection among women.
“The proposal was approved by the Ministry of Health and the Ethics Committee. The approval was based on the evaluation of the content and methodology of the research,” said Dr. Justin Wane, the Chairperson of the committee.
The research is based on microbicide products that contain an ARV compound, Dapirivine that is being developed as vaginal gels, films and rings to help protect women from HIV infection during sexual intercourse.
In an interview with The New Times, the Scientific Manager at the project, Evelyne Kestelyn, said that 400 to 800 participants are expected to enrol in the trials.
“Each participant will engage in the screening process for up to 4 weeks prior to enrolment and will use the investigational product for a period between 15 to 33 months,” said Kestelyn.
She added that, each participant will have an additional six weeks of follow-up to identify HIV-1 seroconversions that are not detected during the product-use period.
Seroconversion is the change from HIV-negative to HIV-positive status during blood testing.
“For Rwanda this means that we will probably start enrolling mid 2011 and the study will take approximately three years,” said Kestelyn.
She pointed out that during the clinical trials, the health and safety of volunteers are put as first priority under standard clinical procedures, which are approved and monitored by regulatory authorities.
The use of microbicides to fight HIV infection was first embraced last year by the Joint United Nations Programme on HIV/AIDS during an international AIDS conference in Vienna.