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Nigerian brothel to test new AIDS pill.

 
 
dlowan
 
Reply Wed 22 Dec, 2004 06:46 am
Excerpted from the Washington Post:

Full story here:
http://www.washingtonpost.com/wp-dyn/articles/A17899-2004Dec21.html?nav=rss_world

Dose of Prevention Where HIV Thrives
Nigeria Brothel Is Test Site for New Pill

By Craig Timberg
Washington Post Foreign Service
Wednesday, December 22, 2004; Page A15

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..............


.......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........

.....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."......


Nothing is simple - the full article raises other issues. Including concerns that, amongst people for whom pill taking when healthy is not a common activity, that sporadic use could help more resistant and virulent HIV strains to appear.
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dlowan
 
  1  
Reply Wed 22 Dec, 2004 06:50 am
And - a nastier AIDS drug story:

Research Flawed on Key AIDS Medicine
Bush Had Planned Its Use in Africa

By John Solomon
Associated Press
Tuesday, December 14, 2004; Page A14

Weeks before President Bush announced a plan to protect African babies from AIDS, top U.S. health officials were warned that research on the key drug was flawed and may have underreported thousands of severe reactions, including deaths, government documents show.

The 2002 warnings about the drug, nevirapine, were serious enough to suspend testing for more than a year, let Uganda's government know of the dangers and prompt the drug's maker to pull its request for permission to use the medicine to protect newborns in the United States.


But the National Institutes of Health, the government's premier health research agency, chose not to inform the White House as it scrambled to keep its experts' concerns from scuttling the use of nevirapine in Africa as a cheap solution, according to documents obtained by the Associated Press.

"Everyone recognized the enormity that this decision could have on the worldwide use of nevirapine to interrupt mother-baby transmission," NIH's chief of AIDS research, Edmund C. Tramont, reported March 14, 2002, to his boss, Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases.

The documents show that Tramont and other NIH officials dismissed problems with the nevirapine research in Uganda as overblown and were slow to report concerns to the Food and Drug Administration.

NIH's nevirapine research in Uganda was so riddled with sloppy record-keeping that NIH investigators could not be sure from patient records which mothers got the drug. Instead, they had to use blood samples to confirm doses, the documents show.

Less than a month after Bush announced a $500 million plan to push nevirapine across Africa to slow the AIDS epidemic, the Department of Health and Human Services sent a nine-page letter to Ugandan officials identifying violations of federal patient-protection rules by NIH's research.

Nevertheless, NIH officials said they remain confident after re-reviewing the Uganda study and other research that nevirapine can be used safely in single doses by African mothers and children to prevent HIV transmissions during birth. But they acknowledged their Uganda research failed to meet required U.S. standards.

As a result, NIH recently asked the National Academy of Sciences to investigate its science in the case and has spent millions in the past two years improving its safety monitoring and record-keeping.

One lesson derived from a closer review of the Uganda research is that even single doses of nevirapine can create instant resistance, meaning patients may not be able to use the drug or others in its class again when their AIDS worsens, Lane said.

Lane said NIH officials were aware in spring 2002 about the impending White House announcement on nevirapine but did not tell presidential aides of the problems because they were confident, even before reviewing the Uganda research, that the underlying science was solid.

The White House -- though unaware of the NIH concerns -- also remains confident in Bush's $500 million plan in 2002 to send nevirapine to Africa. Bush approved $2.9 billion for global AIDS fighting next year.

Senate Finance Committee Chairman Charles E. Grassley (R-Iowa) has asked the Justice Department to investigate NIH's conduct. In a letter released yesterday, Grassley said he was compelled to do so by "the serious nature of these allegations and the grave implications if the allegations have merit."


http://www.washingtonpost.com/wp-dyn/articles/A62360-2004Dec13.html
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