Pubdate: Wed, 22 Dec 2004
Source: Washington Post (DC)
Section: Page A15
Copyright: 2004 The Washington Post Company
Contact:  http://www.washingtonpost.com/
Details: http://www.mapinc.org/media/491
Author: Craig Timberg, Washington Post Foreign Service

DOSE OF PREVENTION WHERE HIV THRIVES

Nigeria Brothel Is Test Site For New Pill

IBADAN, Nigeria -- Crude paintings of women and rows of dimly lit bedrooms 
make clear the purpose of a shabby building just off a main road in this 
sprawling city. But for the next year, this brothel will have another 
function as well: testing a drug that could help stop HIV infections before 
they begin.

About 125 prostitutes here are pioneers in a U.S.-funded study that will 
ultimately involve 5,000 volunteers in seven nations. The study seeks to 
determine whether a single daily dose of an AIDS drug called Tenofovir can 
prevent infection from taking hold in healthy people, the way birth control 
pills prevent conception.

If the pills work -- and if such high-risk groups as prostitutes, soldiers 
and truck drivers can be persuaded to take a pill every day even though 
they are not sick -- researchers said it could slow a disease that is 
devastating Africa and much of the developing world. There are roughly 40 
million people with HIV, the virus that causes AIDS, and there were 5 
million newly infected people in 2003, according to the United Nations.

"Even if it works for 20 percent of the population, it's an improvement 
over nothing," said Isaac F. Adewole, provost of the University of Ibadan 
College of Medicine, who is overseeing the drug trial.

The drug raises a number of scientific and ethical questions, any one of 
which could prevent it from ever being widely administered. But Adewole and 
other researchers say if those questions can be resolved, Tenofovir could 
dramatically curb the spread of HIV by blocking infection in people who are 
most likely to catch the virus and pass it on.

A 1995 trial using Tenofovir blocked the transmission of the simian strain 
of HIV in monkeys. A similar approach has already succeeded in preventing 
infection in rape victims and medical workers exposed to HIV.

Like other antiretroviral drugs, Tenofovir works by keeping HIV from 
reproducing. Researchers say that a daily dose could interrupt the crucial 
first step of HIV, when the virus turns host cells into factories that make 
millions of copies of the virus.

Tenofovir trials are beginning in Nigeria, Ghana, Cameroon, Malawi, 
Botswana and Thailand, as well as in Atlanta and San Francisco.

Among the most appealing aspects of a drug taken daily to prevent HIV, say 
researchers, is that women could take it privately at a time of their 
choosing, without a husband or other sexual partner knowing. Married women 
-- even those who are monogamous -- are among those most vulnerable to AIDS 
because husbands who have sexual relations with other women may be unlikely 
to take precautions or alert their spouses.

"World over, it is much more difficult for somebody in a long-term, 
supposedly faithful relationship to use a condom," Helene Gayle of the Bill 
& Melinda Gates Foundation, which has contributed $6.5 million to Tenofovir 
trials, said from the foundation's headquarters in Seattle.

The most difficult questions about Tenofovir research concern the safety 
and practicality of a long-term daily drug regimen for healthy people, 
particularly in Africa and other parts of the developing world where 
regular use of medicine is uncommon. Taking the drug sporadically, 
researchers say, might provide only partial protection and could encourage 
mutant strains of HIV to develop.

There have also been strenuous objections from AIDS activists concerned 
about the ethics of a study in which half of all subjects receive a placebo 
rather than a drug that could save their lives. During research in 
Cambodia, where 900 prostitutes were being recruited for the trial, an 
organization of sex workers protested, pushing the government to suspend 
the study there this past summer. Hun Sen, the nation's prime minister, was 
quoted as saying, "If a trial is needed, please do it on animals and don't 
use Cambodians."

Complaints have also come from advocates of traditional vaccines and 
microbicides who regard the study as a costly diversion from other 
research. Microbicides are applied to the vagina or rectum before a sexual 
encounter to kill the virus before it can cause infection. Supporters say 
that approach is more practical than taking a pill every day.

"I'm not saying that nobody is going to take it," said Morenike Ukpong of 
the Nigeria HIV Vaccine and Microbicide Advocacy Group. "I'm saying [the 
number] is very low."

The worldwide research project is projected to cost as much as $50 million, 
with the expense divided among the U.S. Centers for Disease Control and 
Prevention, the National Institutes of Health and the Gates Foundation.

The first answers to some of the questions about Tenofovir will come from 
the prostitutes in Ibadan, who were recruited from several brothels and 
have been taking pills since July. Prostitution is legal here, and the 
brothels attract a steady supply of women from the surrounding countryside 
looking for a way to finance schooling, assist struggling families or save 
money to start a business.

Two of the prostitutes, who spoke on condition of anonymity, said they were 
aware of the dangers of HIV and eager to protect themselves with the 
condoms and pills provided by the researchers. Both women, in their early 
twenties, said they had experienced no side effects.

"I take the medicine every day now," said one of the women, leaning over a 
brothel balcony. She was wearing a tight red dress and had coiled her hair 
into tight, spiky braids. Her friend, clad in a sheer black top, cooled 
herself with a plastic fan. "I take my medicine and I use condoms, so I 
think I'm safe," she said.

But like everyone else in the study, these women did not know whether they 
were taking Tenofovir or a placebo. The prostitutes are counseled and given 
unlimited access to condoms, but in a city where 22 percent of all sex 
workers have HIV, researchers expect some to contract the virus during the 
study.

That is the crux of the ethical dilemmas facing the Tenofovir trials. At an 
international AIDS conference in Bangkok in July, an activist group, AIDS 
Coalition to Unleash Power, organized protests and posted signs reading: 
"Tenofovir makes me sick."

Among the demands of AIDS activists is that anybody who contracts HIV 
during the study should be guaranteed lifetime medical treatment. 
Researchers have agreed to arrange for antiretroviral therapy though 
national public health systems, but have argued that to guarantee lifetime 
medical care would drive the cost of the study so high that it would become 
impractical.

Ward Cates, president of Family Health International, a nonprofit group in 
North Carolina, is overseeing several of the trials around the world. He 
said past HIV research showed that even those who received placebos in such 
studies were less likely to become infected than the general population 
because they also received counseling and condoms.

The first results from the study are due in 2006. If Tenofovir is found to 
be safe and effective, it could become available for daily use soon after 
because it has already been approved throughout much of the world for 
treating AIDS. Some even imagine Tenofovir one day being packaged with 
other medicines taken daily, such as birth control pills, to make it even 
easier to use.

"There's not a one-size-fits-all approach for trying to attack the virus," 
Cates said in a telephone interview from his office. "We need a full range 
of HIV prevention measures."