Dr Samuel Kabwigu, co-principal investigator of the planned study in Uganda, told this writer at the just-ended 2012 microbicides conference in Sydney, Australia, that approval from the Uganda National Council for Science and Technology (NCST) and the National Drug Authority (NDA) would determine the actual date when the research starts.
“We can only begin after the two have given us a go-ahead,” said Dr Kabwigu of the Makerere University-Johns Hopkins University research collaboration centre at Mulago. The latter is the designated ASPIRE site for Uganda.
Lisa Rossi, communications director at the Microbicides Trials Network (MTN), a US-based organisation that owns the study and is planning similar ones at MTN affiliated sites in Malawi, South Africa, Zambia and Zimbabwe, said she was “very optimistic” the approvals would be granted soon.
“The Institutional Review Board of our site in Uganda has already approved the study. We have in the past met all the requirements of both the NCST and NDA, so I’m very positive that we’ve done all that’s required of us.”
ASPIRE is targeting up to 3,476 women in the five countries. However, she added, the International Partnership for Microbicides, which developed the Dapivirine ring, is planning a parallel study (IPM 027) on 1,650 women at multiple sites in Africa, using the same product.
Years of research into microbicides for HIV prevention have produced little success, with the best study showing only 39 percent effectiveness against infection.
If ASPIRE or even IPM 027 produces positive results in late 2014 or early 2015, scientists will turn to rings as an alternative to microbicide gels that are used daily or at the time of sex. On the other hand, vaginal rings are products designed to allow the slow delivery of a drug or multiple drugs to cells inside the vagina over a period of weeks or months. And in the case of the dapirivine ring, it has been designed to be used by women for four weeks at a time.
The scientific community is under great urgency to find female-controlled HIV prevention strategies. Over half of the global HIV burden is borne by women. Preliminary results of the 2011 Uganda HIV Indicator Survey released last month show overall prevalence at 6.7 percent in the 15-49 year age group. Of this, prevalence among women stands at a high 7.7 percent, compared to 5.6 percent among men.