San Francisco Chronicle; Thursday, February 19, 1998
David Perlman, Chronicle Science Editor

The experiment -- extremely controversial when it began -- involved giving a short, oral course of the anti-viral drug AZT to pregnant women already infected by HIV, the AIDS virus.

When similar preventive therapy began in a U.S. study four years ago, HIV-positive pregnant women took injections of AZT five times a day for up to four months of pregnancy and throughout labor. Their newborns were given AZT four times a day for six weeks. The infection rate among the infants dropped by 70 percent, and the routine became standard in the United States and most other industrialized countries.

The procedure, however, is extremely expensive and far beyond the reach of many women in Third World countries, where the cost of a single AIDS drug regimen can easily outstrip a developing nation's entire public health budget.

Because of the expense -- plus the difficulty in providing sterile injection needles and the limited numbers of AIDS physicians in the developing world -- scientists at the U.S. Centers for Disease Control and Prevention in Atlanta teamed with the Ministry of Public Health in Thailand and with similar officials in Abidjan, the capital of the Ivory Coast in Africa, for a far shorter and simpler AZT trial.

In the Thailand study, women were given AZT orally only twice a day starting in their 36th week of pregnancy and then again during labor. Their newborns received no drug at all.

The results, according to Thai and U.S. officials, showed that the risk of transmitting the disease from mother to newborn was cut by 51 percent. And although that result was not as good as the more elaborate American method, the short-course regimen is more applicable and more feasible for many countries in the developing world, officials said.

While the Thailand treatment cost about $50 to $80 per woman; the prolonged course costs about $800.

"By using a much shorter course during pregnancy, an oral dose rather than an intravenous dose during delivery, and no infant dose, we evaluated a regimen that could be realistically implemented in developing nations," said Dr. Helene Gayle, the CDC's leading AIDS prevention specialist.

"Now that the regimen has been proven safe and effective in Thailand," said Gayle, "these findings offer hope of extending perinatal prevention to HIV-infected women throughout the developing world."

During the Thailand AZT study, the HIV-infected women were randomly assigned to take either the drug or a placebo, with no AZT, in order to compare results. The use of placebos was sharply attacked by many AIDS specialists as an unethical experiment on Third World women who were being denied known medical help while possibly not understanding their rights as study participants. The controversy raged in AIDS circles for three years.

Thai and Ivory Coast AIDS experts, however, together with their American colleagues, insisted that only placebo controls could validate the results unequivocally.

With 90 percent of the data now reviewed and the experiment declared a success, a joint statement from the three government agencies yesterday said that the placebo trials have been halted and women who had been taking placebos are being given AZT instead. In addition, officials from the CDC, the U.N. AIDS program and the National Institutes of Health said they will recommend that placebo use be stopped in all mother-to-child transmission studies, about a half dozen of which are currently under way worldwide.

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