Cellegy ends phase III microbicide trial in Nigeria

Cellegy Pharmaceuticals on Monday announced that it has ended phase Phase III clinical trials in Nigeria on its microbicide Savvy, the Philadelphia Inquirer reports (Loyd, Philadelphia Inquirer, 8/29).

Microbicides include a range of products - such as gels, films and sponges - that could help prevent the sexual transmission of HIV and other infections (Kaiser Daily HIV/AIDS Report, 8/28).

The trial in September 2004 began enrolling participants. Of the 2,152 women who participated in the trial, half were given Savvy gel and half were given a placebo gel.

The women inserted the gels vaginally prior to each act of intercourse.

The women were followed over the course of one year during monthly visits at which they received HIV tests, informed the researchers about their use of the gel and condoms and reported any side effects they experienced (Cellegy release, 8/28).

The trial, which was funded by USAID, was stopped because the data was not statistically significant, according to an independent monitoring committee (Philadelphia Inquirer, 8/29).

The trial's data monitoring committee observed a "lower-than-expected" HIV transmission rate in the trial, "which was less than half of the expected rate," according to the company.

The company expected a 3.7% annual rate of new HIV cases and the participants had a less than 2% annual rate of new HIV cases, according to a Cellegy release (Cellegy release, 8/28).

The unexpectedly low transmission rate might have been because of the study design, which included distributing condoms and HIV counseling and prevention, the company said.

"We don't know whether the condom is working or whether the product is working," Cellegy Chief Financial Officer Robert Caso said, adding, "To get any further statistical effect, you would have to enlist 2,000 to 3,000 more subjects, almost doubling the trial."

Another microbicide study conducted in Ghana ended in November 2005 for similar reasons.

Savvy is being tested as a contraceptive in clinical trials in the U.S., according to the Inquirer (Philadelphia Inquirer, 8/29).