Pediatric AIDS prevention trial that helped pave way for vision of AIDS-free generation is part of pioneering researcher’s story

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This article originally appeared on the Elizabeth Glaser Pediatric AIDS Foundation blog

Experts in Focus: Dr. Laura Guay

By Chelsea Bailey | April 15, 2014

photo: Plain Dealer

“When it comes to your career, I tell people, ‘you just don’t know.’ Something could come along and change your life, and for me, this was it.” -Laura Guay, M.D.

In August 1988, Laura Guay, M.D. stepped off a plane and into Uganda, a country still reeling from the aftermath of civil war. While the country had been mired in internal strife, a far more insidious and deadly enemy was killing off generations of Ugandans – AIDS.

Dr. Guay arrived in Uganda at the height of the AIDS pandemic. Her team, supported by Case Western Reserve University, was tasked with conducting research to help understand the nature of the epidemic in Uganda. But first they had to overcome one of the biggest global health barriers – infrastructure.

“When I got there everything was sort of decimated from the various coups and civil wars,” she said. “That structure was mirrored in the hospital as well. There wasn’t medicine, there was barely staff – we didn’t even have a phone in our office for the first couple of years I was there.”

What’s more, there was no system in place for dealing with HIV/AIDS.

“The rule when I got there was that you couldn’t actually tell people their status,” she said. “The thought was, there are so few resources and no drugs that you could give patients, so why tell them they were HIV-positive. We quickly changed that mindset in our programs.”

It took years to build the infrastructure needed to provide HIV/AIDS care, treatment, and prevention services, but slowly, Uganda became the African paradigm for how to respond to the AIDS pandemic.

“Uganda started the first HIV testing and counseling center. They had huge education programs in schools and rolled out their national ABC Campaign – Abstinence, Behavior, Condoms – in terms of prevention,” Dr. Guay said.

“Huge amounts of HIV related research and knowledge comes out of Uganda because they established research infrastructure very early on.”


With the mechanisms in place to screen and test patients for HIV, Dr. Guay and her colleagues were able to shift their attention to finding ways to prevent new infections.

By 1994, researchers knew that prevention mother-to-child transmission (PMTCT) of HIV was possible, but the high cost of antiretroviral therapy (ART) made it hard to implement on a global scale.

“In Uganda, the average annual health care expenditure was $3-$4 per person, and you were talking about $1,000 for a mother-infant pair,” Dr. Guay said. “It just wasn’t feasible.”

So while the number of pediatric HIV cases fell sharply in North America and Europe, they continued to climb exponentially in resource-limited settings, including Uganda. Frustrated, researchers began searching for a lower-cost alternative to prevent new infections in babies. The result was the HIVNET012 clinical trial.

The team settled on a drug called Nevirapine, which had been shelved as a long-term HIV treatment option in the United States because it only worked for six to eight weeks before patients developed a resistance to the medication. But for the HIVNET012 team, this was all the time they needed.

“The HIVNET012 clinical trial was designed to say, ‘If we can’t do this very complicated regimen, can we take Nevirapine, something that’s cheap, simple and easy to give around the time of labor and delivery and see how much effect it will have,” Dr. Guay said.

The trial launched in the fall of 1997, comparing the short course of AZT to Nevirapine. Both moms and their babies were given the medications. Researchers and health workers quickly noticed a cohort of the babies born to HIV-positive women appeared to be in better health than the others.

“The short course of Nevirapine worked so much better than the short course of AZT,” she said. “We were able to demonstrate the difference but we didn’t really expect that it would work as well as it did, or that the data would be statistically significant.”

Nevirapine was the drug the global health community needed to launch PMTCT programs in Africa.

“At the time, the results showed that we could do this – even in Africa – with limited resources, and limited amounts of money,” Dr. Guay said. “You can make a difference with this very simple regimen and now is the time to do something about it.”

The Elizabeth Glaser Pediatric AIDS Foundation (EGPAF), initially focused on HIV in children in the United States, reacted quickly to the results and mobilized resources to support some of the first PMTCT programs in Africa.

Today, thanks to organizations like EPGAF and partnerships with the U.S. President’s Emergency Plan for AIDS Relief (PEFPAR), we’ve been able to scale up PMTCT programs and make ART more widely available in resource-limited settings. The global health community has also moved on to even better ART combinations which led to a decrease in mother-to-child transmission of HIV globally.

“EGPAF is leading the way by scaling up the number of PMTCT programs in sub-Saharan Africa,” Dr. Guay said. “Our work will bring us one step closer to the day where we can say, ‘we’ve ended AIDS in children.’

“We’ve made incredible progress, but we can’t slow down because as long as there are infected women, there will be infected babies. We’re not going to eliminate pediatric HIV without continuing until every woman has access to the prevention and treatment services she needs.”

Clinical trials like the HIVNET012 trial helped pave the way for an AIDS-free future. We have the tools and the knowledge to create a generation-free of HIV. Now we must marry knowledge with action.

Dr. Guay continued working in Uganda until 2008, when she joined EGPAF as vice president of research. For the last 30 years, she has witnessed a dramatic change in the AIDS landscape. The disease that was once a death sentence is now a chronic and manageable disease, thanks to early diagnosis and access to care and treatment.

The HIVNET012 trial was supported by the U.S. National Institutes of Health (NIH) and conducted through the Makerere University/Johns Hopkins University Research Collaboration. In addition to her role at EGPAF, Dr. Laura Guay is also a research professor at the George Washington University (GWU) Milken Institute School of Public Health.

For more on the Elizabeth Glaser Pediatric AIDS Foundation, visit here.

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