Pune, October 16: Researchers in India and United States are keenly awaiting the results of a multi-centric trial that focuses on how an HIV-infected mother can prevent the virus from being passed on to her newborn. This ambitious trial that got underway at Pune’s B J Medical College and Sassoon General Hospital in 2002 has been completed. The results to be declared in a week’s time are crucial as they will pinpoint on how to lower the rate of HIV infection to infants who were exposed to breast milk.

In fact, pregnant women who are HIV positive, can halve the chances of passing HIV on to their babies by taking antiretroviral drugs. Treatment options include a one-month course of zidovudine (AZT) during the last weeks of pregnancy or a single dose of nevirapine during delivery followed by a single dose to the infant within 72 hours of birth. In Pune, B J Medical College and Sassoon General Hospital enrolled an approximate 730 women for this trial, dean of the college Dr Arun Jhamkar said.

The principal investigator of the trial, Dr M A Phadke who is also the Vice Chancellor of the University of Health Sciences at Nashik, said the results will be declared shortly. The trial, which is an Indo-US study that costs Rs 2 crore, was sponsored by US-based National Institutes of Health (NIH) and was simultaneously started at other countries, Dr Phadke told The Indian Express.

The follow-up of enrolled participants was underway until September this year. The study in Pune has been done jointly with National AIDS Research Institute, Pune Municipal Corporation and health clinics of Pimpri-Chinchwad Municipal Corporation and other NGOs.

Key investigators in India, US, Ethiopia and Uganda are waiting for the results. “We expect the initial results to be available to all of the investigators soon,” said Phadke. No concerns have been raised about the safety of this trial, according to a communication of international, independent Data and Safety Monitoring Board (DSMB), she added.

The mode of study

India has an estimated 2.5 million HIV-infected individuals and the percentage of HIV cases attributed to mother to child transmission has increased almost ten fold from 0.33 per cent in 1999 to 2.8 per cent in 2004. With an estimated 27 million births occurring annually in India and an assumed vertical transmission of at least 25 per cent in the absence of any mother to child transmission intervention, this is expected to lead to greater than 24,000 HIV infected children each year, researchers Robert Bollinger from Johns Hopkins University and Amita Gupta and Jayagowri Sastry from B J Medical College point out in the August 2007 issue of Indian Journal of Medical Research.

A study of a small group of 41 HIV infected women who chose not to exclusively breast feed their infants was also conducted. The anti HIV drugs were given to the women and the infants also received a single dose of nevirapine. Out of the 42 infants — 32 were formula fed and 10 were mixed fed. Four infants were diagnosed with HIV infection. Out of the formula fed babies, transmission occurred in only one infant at fourteen weeks. This small study suggests that a short course of AZT or a single dose of NVP is effective in reducing Mother to Child transmission in the Indian setting.