“An end is in sight, the tools are in hand, and together we can make this happen.”

Dr. Maureen M. Goodenow, Ph.D., serves as the Director of the Office of AIDS Research in the Office of the Director at the U.S. National Institutes of Health. As a leading expert in HIV/AIDS research and global health and a respected author of more than 100 articles and book chapters, Dr. Goodenow is dedicated to the development of the next generation of scientists. Team EGPAF was honored to speak with her recently on her professional journey, and how research can pave the way to an AIDS-free generation.

Team EGPAF: What initially led you to HIV/AIDS Research?

Dr. Maureen M. Goodenow: My doctoral and fellowship studies were focused on the molecular biology of retroviruses in animal models and their role in cancer. I had an opportunity to work as a visiting scientist at the Pasteur Institute in Paris in the late 1980s, which opened the door to studies of HIV, a virus related to the animal retroviruses. The acute HIV pandemic and the critical research questions related to the virus causing a fatal immune deficiency in humans were a natural progression of my research at that time.  The group I was with at Pasteur was among the first to apply the new technology, PCR or the polymerase chain reaction, to quantify the genetic diversity of the virus populations, how the virus changed over time, and how virus infections could be detected.

EGPAF: When did you know it would define your career?

MG: The HIV studies at Pasteur provided data for my first grant applications as a junior faculty at the University of Florida. At that time, the Pediatric AIDS Foundation (PAF) was supporting basic research, and I was fortunate to have terrific pediatric collaborators, including Dr. John Sleasman, who partnered in projects to use the genetic diversity of HIV to study mother-to-child transmission. The first extramural funding for my HIV research came from PAF, and then subsequently from the National Institutes of Health (NIH). PAF support was foundational to the development of more than 30 years of my research career.

EGPAF: What was your experience with the Elizabeth Glaser Pediatric AIDS Foundation? How did this experience impact your career in HIV/AIDS research?

MG: My academic research was continuously funded by public and private extramural sources, including the NIH and the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF). I served as the EGPAF Scientific Advisor for Research Awards and had the opportunity to meet Elizabeth and her family, as well as Dr. Philip Pizzo from the NIH National Cancer Institute (NCI), who developed the first trials of HIV protease inhibitor therapeutics in children with HIV.

My experience with EGPAF was transformative and helped cement my commitment to HIV/AIDS research. EGPAF addresses urgent needs in pediatric HIV/AIDS in the world’s most affected regions. I was moved by Elizabeth Glaser’s vision and EGPAF’s mission to create a world where no mother, child, or family is devastated by HIV.

Early in my career, in the 1990s, I studied the persistence of multiple maternal genotypes of human immunodeficiency virus type 1 in infants infected by vertical transmission and rapid telomere shortening in children, which advanced HIV research in mother-to-child transmission (MTCT) and pediatric HIV. Subsequent research identified novel characteristics of gestational viral genotypes that could identify mothers at high risk of transmitting HIV to their infants during breastfeeding. More recently at the NIH, my research group has been studying immune inflammatory modulation of recreational marijuana use by youth infected by HIV.

EGPAF: Can you speak to the importance of including pregnant women and children in HIV research?

MG: Together, we have made great strides to transform the perinatal and pediatric HIV epidemic. As noted in a recent UNICEF brief, Going the “Last Mile” to EMTCT: A Road Map for Ending Paediatric HIV Worldwide, between 2000 and 2018, the number of new child infections resulting from MTCT was reduced about 60 percent, from less than 400,000 to 160,000. Although this progress is noteworthy, much work remains. UNAIDS Start Free, Stay Free, AIDS Free estimates that during 2019, there was 85 percent ART coverage among pregnant women and approximately 150,000 new pediatric HIV infections. We must renew our commitment to eradicating MTCT universally. This requires intentional inclusion of women and children from different populations and social circumstances to develop prevention and treatment modalities that fit diverse needs.

EGPAF: What strategies do you think could improve the inclusion of these populations in clinical research?

MG: There has been a recent call to action to improve the inclusion of pregnant and lactating women in research. Key findings from the Task Force on Research Specific to Pregnant Women and Lactating Women were presented to the U.S. Department of Health and Human Services (HHS) Secretary in August 2020. Among these recommendations are the removal of regulatory barriers that limit the ability of pregnant women to participate in research and the implementation of an awareness campaign and evidence-based communication strategies to engage health care providers and the general public in this discussion. Importantly, the recommendations also include the need to mitigate liability issues and other disincentives that limit inclusion.

Workshops and working groups organized by the World Health Organization (WHO) and International Maternal Pediatric Adolescent AIDS Clinical Trials Network have accelerated this call for HIV research and recommend the intentional engagement of community and stakeholder networks to help reframe the position from inclusion strategies to requiring justification for the exclusion of pregnant women in HIV research.

EGPAF: What do you consider the most exciting research breakthroughs in recent years?

MG: The first clinical trial to show efficacy of a single drug, zidovudine (AZT), to prevent maternal-infant transmission of HIV was the Pediatric AIDS Clinical Trials Group Protocol 076, a landmark study led by the NIH Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and Dr. Lynne Mofenson, who helped design and conduct the clinical trial in the early 1990s. Findings showed that viral transmission was reduced by approximately two-thirds when AZT was provided to pregnant women with HIV and to their newborns, and that turned the tide on pediatric AIDS. This trial led to the short-course AZT trial, which formed the backbone of country efforts to reduce MTCT on a population level through the widespread use of AZT.

Evidence gathered from maternal-pediatric studies provided the rationale for the NIH-funded HIV Prevention Trials Network (HPTN) 052 study, which showed that people with HIV who achieve and maintain an undetectable viral load by taking HIV medication daily as prescribed cannot sexually transmit the virus to others—a concept known as Undetectable=Untransmittable (U=U), which has had widespread implications for preventing HIV transmission.

For some lifestyles and circumstances, it may not be desirable to take a daily pill. Recent breakthroughs with long-acting forms of HIV treatment and prevention are momentous because they pave the way for more options. The U.S. Food and Drug Administration has approved the use of long-acting injectable cabotegravir/rilpivirine for HIV treatment. We eagerly anticipate the approval of long-acting cabotegravir for prevention, based on the overwhelming evidence that the long-acting injectable is highly effective at preventing HIV among cisgender men who have sex with men and transgender women who have sex with men, and among cisgender women (see studies HPTN 083 and HPTN 084 respectively).

At NIH, we make deliberate efforts to rapidly translate research breakthroughs into clinical care. The Perinatal HIV Clinical Guidelines Panel is a working group of the NIH Office of AIDS Research Advisory Council (OARAC). This panel convenes perinatal HIV experts across North America to review pregnancy, lactation, and pediatric data regularly to produce federally approved medical practice guidelines for HIV/AIDS to prevent perinatal HIV transmission.

EGPAF: What advances do you hope to see in the future?

MG: Progress achieved with new technologies and global partnerships gives me hope that in the next 10 years we will see equitable access to HIV care, prevention, and treatment; significant expansion of the prevention and treatment toolkits; notable reduction in stigma; increased public commitment to address health disparities and social determinants of health; a notable decline in HIV infections globally; and significant advances in HIV vaccine research.

It’s encouraging that a handful of countries and six states and territories recently received WHO validation for eliminating MTCT, including Anguilla, Antigua & Barbuda, Armenia, Belarus, Bermuda, Cayman Islands, Cuba, Malaysia, Maldives, Moldova, Montserrat, Sri Lanka, St. Christopher & Nevis, and Thailand. It’s quite an achievement, and I look forward to this effort accelerating.

As noted by AVAC: Global Advocacy for HIV Prevention, “funding, focus, implementation, and research” are essential to accelerating HIV prevention and ending the HIV pandemic. I remain optimistic that we will develop effective cure and vaccine strategies to eliminate HIV. To end the HIV pandemic, the global community must continue to work collaboratively to produce discoveries and identify approaches that will optimize HIV treatment and prevention options for diverse populations. Beyond a whole-of-science approach, a whole-of-society approach is essential, with new and varied partnerships across all sectors (public, private, and nongovernmental organizations), with participation from researchers, health care providers, public health and policy experts, educators, economists, communities, and advocates. An end is in sight, the tools are in hand, and together we can make this happen.

EGPAF: Do you think the changes the world has experienced through the COVID-19 pandemic will translate to learnings and support for HIV/AIDS research?

MG: Yes. The changes catalyzed by COVID-19 are informing HIV research, just as our knowledge of HIV informed work on COVID-19.

Valuable lessons from the COVID-19 pandemic have opened the door for new progress with HIV. COVID-19 has accelerated widespread use of telemedicine and the quick ramp-up of clinical trials and development of novel diagnostic platforms. These lessons learned can be used to advance HIV prevention, treatment, and—ultimately—cure options.

Critical lessons learned from the 40-year history of HIV research accelerated the extraordinary response to the COVID-19 pandemic. From the mRNA vaccine platform to clinical trials networks for testing candidate vaccines to rapid testing and molecular epidemiology for tracking, the HIV research footprint is apparent in these COVID-19 research outcomes.