FHI to end microbicides trial in Nigeria

August 31, 2006 :: Beth Robinson Family Health International(FHI)

Family Health International (FHI) has announced that it plans to stop a study being conducted in Nigeria to determine whether a vaginal microbicide gel, Savvy, is safe and effective for reducing women's risk of acquiring HIV infection. This decision followed a recommendation during a meeting of the study's external, independent Data Monitoring Committee (DMC). After reviewing the study data to date, DMC members concluded that the Nigeria trial was unlikely to provide convincing evidence that Savvy protects against HIV. Without obvious signals of effectiveness in the interim data,the study would be unlikely to detect a reduction in the HIV risk if it were to continue. "Based on the data available, there was little reason to expect that the product would prove effective if the trial went to completion," says Dr. Paul Feldblum,principal investigator of the Nigeria study and an epidemiologist at FHI. "We believe resources are better used to fund studies of more promising products to reduce HIV risk." The trial was part of an international effort to evaluate microbicides as a tool to reduce the risk of HIV infection in people at high risk. With funding from the United States Agency for International Development (USAID), Family Health International has been working to see if Savvy is effective in reducing male-to-female transmission of HIV among women in West Africa. The Savvy trial in Nigeria began screening volunteers in September 2004 and completed planned enrollment with 2,152 women in June 2006. Half of the women were given Savvy gel, and half were given a placebo gel to be inserted vaginally with pre-filled applicators before each act of intercourse.At monthly visits during a year-long follow-up, each participant was tested for HIV and reported on use of the gel and condoms, and any side effects or medical problems. Each participant also received counseling on reducing her risk of HIV and was given condoms for use during all sex acts. These measures may have contributed to the lower than expected rate of new HIV infections in the Nigeria study population. At trial initiation, the anticipated annual rate of new HIV infections in this population was 3.7 percent.But almost two years into the study, annual HIV incidence among study participants was less than 2 percent. After slightly less than half the expected number of HIV infections was observed, no evidence of product effectiveness was found.The preliminary data showed no statistically significant differences in HIV infection rates between the group of women using Savvy and those using the comparison placebo gel. The rates of side effects and more serious medical problems were similar in the two groups, and study participants experienced no serious medical problems deemed related to product use. To date, nearly 70 percent of the women currently in follow-up have completed all planned visits. Each woman who has not already completed the study will be informed of the study closure at her next scheduled follow-up visit, when she will receive a final HIV test. Once all the remaining follow-up visits have been completed, FHI will analyze the data and report the study results. The decision to close the Savvy study in Nigeria follows the early stoppage of a similar Savvy trial in Ghana in November 2005 that also observed fewer HIV infections than expected and therefore was similarly unable to determine whether Savvy was effective. With two large studies that together fail to provide even preliminary evidence of the effectiveness of Savvy gel, at this point FHI will not pursue further research on the product for HIV prevention. (This decision does not affect the trials other organizations are conducting in the United States to determine if Savvy is effective as a contraceptive.) Should an effective microbicide become available, all parties are committed to returning the benefits of research to the communities where the studies were conducted. Effective HIV prevention tools should be available to everyone, especially the women who have contributed to the search through their participation in microbicide studies. FHI looks forward to continuing to work with partners on studies of other microbicides with the potential to help prevent HIV and complementary HIV prevention approaches, such as antiretroviral treatment for pre-exposure prophylaxis.