The National Institute of Allergy and Infectious Diseases (NIAID) today announced that it is restructuring its HIV/AIDS clinical trials networks and soliciting investigators and institutions to lead the reorganized effort. This reorganization, designed in response to both the changing face of the AIDS epidemic and evolving scientific challenges, will enable NIAID and its many collaborators to effectively continue their research for safe, effective and affordable drugs, preventive strategies and HIV vaccines. The new network leadership that will be established through this process will direct, coordinate and conduct NIAID-funded HIV/AIDS clinical research both domestically and internationally. NIAID, part of the National Institutes of Health (NIH), supports the world’s largest portfolio of clinical research in HIV prevention, vaccine and treatment.

“This clinical leadership solicitation reflects our vision to improve coordination, collaboration and flexibility in NIAID-supported HIV/AIDS prevention, vaccine and treatment research,” says NIAID Director Anthony S. Fauci, M.D. “The current NIAID AIDS research structure was critical to the discovery of antiretrovirals to treat HIV-1 in adults and children; the development of strategies to successfully prevent mother-to-child HIV transmission; and the significant progress in the global search for an AIDS vaccine. This newly designed clinical research structure will now provide us with the opportunity to build on those successes and address future global research challenges.”

The leadership solicitation, known as a Request for Applications (RFA), is now available for review by interested parties on the NIAID Web site (see below for details). A second RFA, to be released in early 2005, will solicit applications for the Clinical Trial Units (CTUs) that will implement the research plans of the networks. Funding for the two RFAs is expected to total up to $300 million for the first year, and funding may continue for up to seven years.

The research structure resulting from this competition will enable NIAID’s Division of AIDS to more effectively respond to global research needs, including those of people of color, those who live in poverty, and women, all of whom are increasingly affected by the HIV/AIDS pandemic and continue to be under-represented in clinical research.

“We are pleased to be making this announcement on World AIDS Day,” says Dr. Fauci, “as this year’s World AIDS Day theme focuses on ‘Women, Girls, HIV and AIDS’.”

Each network leadership group selected as part of this competition will work with NIAID and other NIH Institutes on a focused research effort. To most effectively coordinate across disciplines, each network can address significant scientific questions in one or more of six priority research areas

• Developing HIV vaccines
• Translating research insights into therapeutic products to treat HIV disease
• Optimizing clinical management of HIV/AIDS, including co-infections and other HIV-related conditions
• Developing microbicides to prevent HIV acquisition and transmission
• Preventing mother-to-child transmission of HIV
• Developing other methods of HIV prevention

The decision to revamp the clinical research structure emerged following extensive consultations with researchers, clinicians, community, nurses, advocates and people living with and at risk for HIV/AIDS. The new approach is designed to increase the efficiency, accountability and integration of NIAID’s HIV/AIDS clinical research networks and enhance their capacity to effectively conduct vital clinical research, especially in resource-limited settings. Specifically, the new clinical research structure will

• Maximize scientific opportunities by integrating and coordinating HIV/AIDS prevention, vaccine and therapeutic research and maintaining a flexible and responsive approach to emerging research challenges
• Build and strengthen HIV/AIDS research capacity, especially in resource-limited settings
• Improve research efficiency through the shared use of key support services
• Improve evaluation methods to ensure that the highest research priorities are addressed

Application Information

Any domestic public or private organization, profit or nonprofit, can apply under the leadership RFA. These organizations include universities, colleges, hospitals, laboratories, divisions of state and local governments, and eligible agencies of the U.S. federal government.

A pre-application meeting for those interested in the leadership RFA will be held on December 13 on the NIH campus in Bethesda, MD. Applications will be evaluated on the basis of the scientific merit of the proposed program components as determined by peer review, NIAID’s programmatic priorities and the availability of funds. Between three and six network leadership groups will be funded; the number will be determined by the scope and quality of the clinical programs proposed by the group of applicants. The earliest anticipated award date is March 2006. Copies of the Leadership RFA and information on the pre-application meeting can be obtained at http://www.niaid.nih.gov/daids/rfa/network06.

NIAID is a component of the National Institutes of Health, an agency of the U.S. Department of Health and Human Services. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on transplantation and immune-related illnesses, including autoimmune disorders, asthma and allergies. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov.