Correspondence
Studies in Thailand of the Vertical Transmission of HIV
N Engl J Med 1998; 338:843-844March 19, 1998
- Article
To the Editor:
We agree with Dr. Phanuphak that investigators are obliged constantly to evaluate and elevate the ethical context of a study conducted in a clinical setting.1 But Dr. Phanuphak criticizes our observational study, funded by the National Institutes of Health (NIH) and designed to characterize mucosal immunity and viral correlates of perinatal transmission of the human immunodeficiency virus (HIV). His criticism is that zidovudine was not provided to study participants. Our study does not evaluate an intervention to prevent transmission, but seeks to provide a scientific basis for new interventions to reduce the transmission of HIV. However, all the investigators in this study have endorsed the use of any available medication, including antiretroviral therapy, that the attending physicians deem appropriate.
The study is being conducted at a Royal Thai Ministry of Public Health hospital by physicians under the direction of the ministry. The study was reviewed and approved by the NIH and by institutional review boards at Johns Hopkins University, the U.S. Department of Defense, Chiang Mai University, and the ministry of health. Informed consent was obtained, and the prevailing standard of care for HIV-infected adults and pregnant women in Thailand was uniformly applied throughout the study. As noted by Phanuphak, the use of zidovudine to interrupt vertical transmission was not the standard of care in Thailand when these studies were designed and begun. The transmission rate in our observational study will be reported in a future paper.
Dr. Vichai Choke-wiwat, secretary of the institutional review board of the ministry of health, recently stated that the ministry cannot accept the AIDS Clinical Trials Group study 076 regimen as the standard of care in Thailand.2 Alternatives to the 076 regimen should be evaluated in the context of sound scientific study designs. As soon as a study of short-course zidovudine was initiated at Lampang Hospital in Lampang, Thailand, in July 1997, the investigators in our study aggressively and promptly offered enrollment to HIV-infected pregnant women in this study. In consequence, all volunteers in our observational study are now also offered participation in an open-label evaluation of a short course of zidovudine (zidovudine initiated at 34 to 36 weeks of gestation), sponsored by the Thai Centers for Disease Control and Prevention and the ministry of health. Twenty-nine women have received zidovudine on this basis.
We and our Thai colleagues have been eager to incorporate, during the course of our study, any safe, sustainable, and effective intervention that reduces mother-to-infant transmission of HIV. We all fervently hope that short-course zidovudine will prove effective and allow a standard of care to be established that can then be the basis for all future studies, observational or interventional.
2 ReferencesMerlin L. Robb, M.D.
Walter Reed Army Institute of Research, Washington, DC 20850Chirasak Khambaroong, M.D., Ph.D.
Chiang Mai University, Chiang Mai 50202, ThailandKenrad E. Nelson, M.D.
Johns Hopkins University, Baltimore, MD 212051
Phanuphak P . Ethical issues in studies in Thailand of the vertical transmission of HIV. N Engl J Med 1998;338:834-835
Full Text | Web of Science | Medline2
Choke-wiwat V. Use of drugs to prevent transmission of AIDS from mother to child in Thailand. Mati-Chon. October 8, 1997:9.
To the Editor:
Several institutions are involved in a study of mother-to-infant transmission in Lampang Hospital, northern Thailand, including the Research Institute for Health Sciences of Chiang Mai University, Lampang Provincial Hospital of the Ministry of Public Health, the Walter Reed Army Institute of Research, and Johns Hopkins University. The aim of the study is to correlate viral and immunologic data from mucosal and systemic specimens with transmission outcomes. The study is not a placebo-controlled trial of zidovudine. Information gained from this study is crucial for understanding vertical transmission of HIV subtype E, which may differ from that of subtype B. The study was approved by local and national ethics review committees in Thailand.
At the time we started the study, the standard of care regarding the use of zidovudine for reducing vertical transmission had not been formulated. There was also no zidovudine available for distribution to provincial hospitals through the ministry of health. Since zidovudine is not the standard of care in the region, its availability solely through the research study would represent an unethical coercive enticement or inducement to participate. In addition, the use of zidovudine without the appropriate infrastructure and coordination would be disruptive and might detract from established elements of health care delivery. On the other hand, provision of powdered milk is accepted as the standard of care for the Royal Thai Ministry of Public Health hospital system, and all participants in our study are provided adequate milk from the research project. Finally, the conduct of research provides a basis for establishing health care policy, but it is not the proper avenue for effecting change directly.
In July 1997, when enrollment in our study was nearly finished (with 109 subjects enrolled), the inspector general of the ministry of health in the upper northern region of Thailand started an assessment of the effect of zidovudine on vertical transmission of HIV type 1. The purpose of the research is to produce information for the further development of a standard of care for the country. Lampang Hospital is one of the sites for this effort by the ministry, and all HIV-positive pregnant women who attend the antenatal clinic at this hospital receive zidovudine. Since then, subjects who meet eligibility criteria for zidovudine treatment and are enrolled in our observational study have also been receiving zidovudine.
Suchint Wongchoosri, M.D.
Manu Wera-arpachai, M.D.
Vilaivan Gulgolgarn, M.D.
Witaya Ketsararat, M.D.
Lampang Hospital, Lampang 52000, ThailandNopporn Sittisombut, M.D., Ph.D.
Sodsai Tovanabutra, Ph.D.
Chiang Mai University, Chiang Mai 50202, Thailand- Citing Articles (2)
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