Newsday - July 13,2000
Laurie Garrett, Staff Writer

The bombshell fell on the 13th International AIDS Conference yesterday when Dr. Lut Van Damme of the Institute of Tropical Medicine in Antwerp, Belgium, announced the results of a large-scale study of the spermicide nonoxynol-9.

The study, conducted in six cities where HIV rates are high, involved 990 prostitutes. They were given one of two products: a gel product called COL-1942, trade-named Advantage-S, that contains nonoxynol-9; or a placebo, Replens, a neutral gel typically used to counter vaginal dryness during menopause.

The women were tested for HIV infection before the study began and were monitored for several months, until the study was halted because of the high infection rate.

"It is an understatement to say that we were extremely disappointed" when results showed more HIV infections among the women using the nonoxynol-9 product, Van Damme told the stunned conference audience.

Fifteen percent of the women using nonoxynol-9 got HIV infections, compared with 10 percent of the placebo group. "These results are a clear setback," Van Damme continued.

Health officials from all over the world were at pains yesterday to figure out what the UN AIDS Program study means. Should all nonoxynol-9 products be banned? What is the biological basis for the unexpected result? What does this finding mean for the future development of microbicides to prevent sexual transmission of HIV?

"The results of this trial are a surprise and a disappointment to all of us," the World Health Organization's Tim Farley said at a news conference.

"The bottom line is if you use nonoxynol-9 [to prevent infection] you are not only wasting your money, but you might be wasting your life," Jos Perriens of the UN AIDS Program said. His agency released an official statement: "UN AIDS believes that women at high risk of HIV infection should not use nonoxynol-9, given that the bulk of the data now suggests that it is either ineffective or harmful as an anti- HIV agent."

Speaking on behalf of the manufacturer, Columbia Laboratories of the United States, Howard Levine insisted that "the statement that nonoxynol-9 is harmful is excessive. The high-risk women in the study had up to 20 partners a day. That's way above our four-times-a-day use that we tested...We really have to look very carefully at what we say...and wait to the final analysis."

Dr. Helen Rees, chairwoman of the South African Medicines Control Council, said she "would like to get the final report as quickly as possible" because her government makes condoms containing nonoxynol- 9 and because two South African cities, Johannesburg and Durbin, were included in the study.

Dr. Salim Abdool Karim, who conducted the Durbin portion of the study, yesterday recounted in an interview that last fall the spermicide looked promising as an agent to stop HIV transmission. The study began as "blinded," meaning that neither the researchers nor the prostitutes knew who was receiving which product. But eight months ago it became obvious that one group was showing far better results than the other.

So in December UN AIDS decided to stop the study, break the blinded codes and analyze the findings.

"I heard about it the day after the code was broken, and I was depressed for a week," Karim continued. "Having this negative result sets back our agenda for microbicides."

Dr. Lynn Paxton of the U.S. Centers for Disease Control and Prevention was scrambling yesterday to figure out what the implications were for Americans. The study found that the more times a woman used nonoxynol-9 each day, the more likely she was to become infected with HIV. The difference was affected by whether or not condoms were used; those who did not use them were nearly three times more likely to have acquired HIV compared with those who insisted that condoms always be used.

In the United States, the heaviest nonoxynol-9 users are gay men who use rectal lubricants containing the chemical, Paxton said. The study, coupled with two new studies of mice that found nonoxynol-9 harms mucosal cells lining the rectum, led her to conclude: "I think nonoxynol-9 should not be used among gay men, because it could be harmful, I believe."

She said women's use of nonoxynol-9 foams and gels on diaphragms and contraceptive sponges "needs to be evaluated."

In Rockville, Md., U.S. Food and Drug Administration spokeswoman Laura Bradbard said: "Any data that is out there to support this is of interest to FDA, but we would not comment on anything we haven't reviewed."

What role the chemical may have in condoms is unknown, but Dr. Ron Gray of the Johns Hopkins Medical Institute in Baltimore took some comfort in the fact that "at least nonoxynol-9 is on the penile side [of the condom] rather than the vaginal side."

Dr. Nancy Padian now has to decide what to do with a warehouse full of nonoxynol-9 gel in Harare, Zimbabwe. Padian, a University of California in San Francisco researcher, was set to begin a study there of nonoxynol-9 use by women in Harare.

Indeed, all of the AIDS researchers and officials at this conference were at pains to say that microbicide research cannot be slowed by this setback. "This is not the death knell for microbicides," Paxton said. "It can't be."

With HIV spreading fastest worldwide among women, there is a desperate need for a female-controlled form of HIV protection.

But it's urgent that questions be answered, insisted Lori Heise of the Global Campaign for STI-HIV Prevention Alternatives for Women, a Washington, D.C.-based coalition. First, why does nonoxynol-9 seem to promote HIV infection? The chemical acts as a detergent that stops sperm by breaking up the membranes of spermatozoa. Scientists had hoped the compound would have a similar effect on the envelope of HIV. Instead, nonoxynol-9 may have played a role in making the membranes of cells lining the vagina more vulnerable to infection.

Heise also wants to know why one of the study cities-Abidjan, Ivory Coast-had findings counter to results in the other five. The incidence of HIV among women who used the spermicide there was zero, compared with 8.3 percent in the placebo group. One factor researchers pointed to was that women in the Abidjan study said condoms were always used.

000713
ND000713

Always watch for outdated information. This article first appeared in 2000. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 2000. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .