Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.
Bangkok Post Jan 28, 1998
Aphaluck Bhatiasevi
The Data Safety Monitoring Board of the National Institutes of Health of the United States was supposed to announce the results of the trial conducted on 370 pregnant women in Atlanta, Georgia late last week, but after opening the code of the study, changed its mind and decided to reveal the results after administering the delivery of babies of 12 more pregnant women in the study.
The report entitled "Phase 3 randomised placebo controlled trial to evaluate the safety and efficacy of short course oral antinatal zidovudine to reduce perinatal HIV transmission - Bangkok, Thailand" involves 392 pregnant women.
Carried out by the HIV/Aids Collaboration Centre (a joint activity of Thailand's Ministry of Public Health and the US Centres for Disease Control and Prevention), the study began in May 1996 at Siriraj, Rajvithi and Children's hospitals in Bangkok.
"Though the study results are not revealed, a reduction is observed in the rate of HIV transmission from mothers to infants," said a researcher.
The study involves the use of a placebo or fake drugs, where both researchers and patients do not know who is given the actual drug and who is given the placebo.
If proven successful, the results of the study will be announced as standard treatment for HIV positive pregnant women who visit state hospitals in Thailand and many other developing countries, said the source.
If proven successful, the short course study will benefit Thailand and many other developing countries who currently cannot afford the 076 regimen, said sources.
This short course study is to measure effectiveness of the use of AZT for a shorter time period, in reducing vertical transmission of HIV from pregnant women to newborn infants.
Though many countries around the world use the results of Aids Clinical Trial Group (ACTG) 076 of the US as a standard for treatment on HIV positive pregnant women to reduce transmission to their babies, it is not considered standard practice in many developing countries, including Thailand.
The ACTG 076 regimen announced four years back is considered too expensive and difficult to administer because it requires the patient to take 500 mg of AZT five times a day at the first 14-28 weeks of pregnancy and intravenously during labour. Under the ACTG 076, where children have to be given AZT after birth for at least six months, it is said to reduce HIV infection among newborn by 8-25 percent.
The short course involves daily provision of two doses of 300 mg of AZT to pregnant women one month before delivery and every three hours during labour until delivery.
The drug is not intravenously given to children under the short course study because it would become more costly and would be difficult for all hospitals throughout the country to administer to newborn patients.
The short course regimen is expected to reduce costs of AZT use by half of that of ACTG 076 or would cost 3,000 baht per person per month (based on 26 baht per dollar rate), according to study documents.
Perinatal HIV transmission is considered a major Aids problem in the country, but since most pregnant women visit hospitals in the late third trimester of pregnancy or during delivery, a short course regimen is thought to be the best method of treatment, said sources.
In Bangkok, the mother-to-child HIV transmission rate is 25 percent while in the northern provinces it is 40 percent.
The study was earlier heavily criticised by US NGO Public Citizen's Health Research Group and the New England Journal of Medicine for using a placebo in its trials despite knowing that AZT could help reduce perinatal transmission of HIV.
980128
BP980104
Copyright © 1998 - The Bangkok Post. Reproduction of this article (other than one copy for personal reference) must be cleared through the Bangkok Post.
AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from Broadway Cares/Equity Fights AIDS, Elton John AIDS Foundation, the National Library of Medicine, Pacific Life Foundation and donations from users like you.
Always watch for outdated information. This article first appeared in 1998. 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, 1998. 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. .