Background—Refining NIH’s HIV Clinical Trials Enterprise

The HIV clinical trials network Funding Opportunity Announcements (FOAs) issued in January 2019 contain changes from how the NIH HIV clinical trial networks have previously been structured, particularly with regard to research on microbicides for HIV prevention and pediatric HIV research. The below questions and answers provide more information on these changes.

Why is a microbicide network absent from these FOAs?

Finite resources are available for NIH research funding on HIV. Thus, we must make smart choices on resource allocation for the HIV clinical research infrastructure. To reduce costs while maintaining commitment to advancing the most promising science, NIH plans to streamline two existing HIV prevention networks into one. This will reduce administrative and oversight costs, allowing more funds to be allocated to fund the clinical trials to advance new prevention tools and strategies.

Will microbicide research be supported under the prevention network?

When new, meritorious, innovative concepts for HIV prevention emerge, NIH will support their clinical evaluation. Clinical trials, particularly late-stage clinical trials, are resource-intensive. To merit investment, prototype HIV prevention technologies must demonstrate preliminary evidence that they are likely to be safe, effective, desirable and implementable in target populations.

NIH will follow these criteria for determining investment in HIV prevention tools:

  • Is the proposed technology likely to be safe?
  • Is the proposed technology likely to be effective? Can efficacy compare to current tools, including PrEP, which is 90% effective when used correctly? Increasingly, HIV prevention trials will need to be designed as head-to-head comparisons with PrEP. If a prevention tool cannot match PrEP’s efficacy, it will be difficult for it to progress when the most effective, currently available tool is superior in that regard.
  • Can the proposed technology be implemented on a scale that would diminish new infections in groups most affected by HIV? For example, will this product offer a prevention solution for women in southern Africa, or young black MSM in the U.S.?

Will the successful HIV prevention clinical trial network applicant only support long-acting, systemic HIV prevention tools?

Adherence to HIV prevention tools is critical for protection, but adherence remains challenging for people seeking protection from HIV. Further, HIV prevention tools for women need to protect them from both vaginal and anal exposure to HIV. Similarly, HIV prevention tools for men need to protect during both receptive and penetrative intercourse.

This type of sustained and “systemic” protection could be developed to work via a range of tools that offer choices to people seeking protection from HIV. Yet, there remains a significant behavioral and social science agenda that needs to be integrated into prevention concept design to ensure that these products fit in individuals’ lives. Therefore, to be considered for NIH-funded clinical support, prevention concepts must provide significantly better potential for adherence and appropriate protection. In addition, these concepts must also be attractive to partners who could ultimately implement these tools to be considered for NIH-funded clinical support.

What is included in these FOAs to ensure that women will be taken into account for HIV prevention research?

NIH’s goal is to develop prevention tools that move the needle on the epidemic, particularly for disproportionately affected groups like young women. Developing and testing new HIV prevention tools that work for young women, will be among the highest priorities for the new HIV prevention clinical trials network. NIH’s goal is to develop an array of choices for women and men that offer different methods of safely and effectively preventing HIV and are desired by those with diverse preferences and circumstances.

Why is the new HIV maternal, adolescent and pediatric clinical trials network to be solely focused on treatment?

Maternal and pediatric HIV research is a high priority for NIH. Specifically, the following are key aims for NIH’s clinical trials networks:

  • Prevent sexual transmission of HIV in adolescents
  • Evaluate HIV vaccines in pediatric populations
  • License newer antiretroviral therapy (ART) during pregnancy, at birth, through childhood and adolescence
  • Establish ART-free remission from infancy through adulthood
  • License newer tuberculosis (TB) medications during pregnancy, at birth, through childhood and adolescence
  • Define new TB treatment and prevention strategies across the lifespan, including developing a vaccine
  • Conduct limited studies of co-morbidities, specifically neurologic and cognitive issues
  • Evaluate vaccines for other infectious diseases in HIV-exposed and HIV-positive children

To capitalize on these opportunities, the structure of the pediatric and maternal clinical research enterprise must evolve. 

Adolescent HIV prevention and vaccine research will be integrated into the proposed HIV prevention and vaccine research networks, with dedicated pediatric and adolescent medicine expertise to help lead the planning, conduct, and analysis of these clinical studies. These studies will also be conducted in collaboration with the NIH Adolescent Medicine Trials Network for HIV/AIDS Interventions to leverage adolescent medicine expertise and site capacity.

NIAID and the Eunice Kennedy Shriver National Institute of Child Health and Human Development will support a re-focused maternal and pediatric therapeutics clinical research network that will work closely with HIV treatment clinical trials network and other groups as appropriate. This approach will foster collaboration and allow trials to move swiftly from planning to execution to results.

NIH plans to maintain or expand the capacity of current HIV clinical trial sites across prevention, vaccines, and therapeutics research to accommodate additional study participants in these key research areas.

This approach to maternal and pediatric HIV research, which prioritizes existing expertise while leveraging comprehensive knowledge across the NIH HIV/AIDS clinical trial networks, will deliver the tools and knowledge to dramatically reduce the burden of HIV disease among women and children. 

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