What are the NIAID HIV/AIDS clinical trials networks?

The National Institute of Allergy and Infectious Diseases (NIAID) HIV/AIDS clinical trials networks are an affiliated group of national and international medical research institutions and investigators that conduct clinical HIV/AIDS research to develop safe and effective drugs, prevention strategies and HIV vaccines. Each network is spearheaded by a principal investigator and supported by a core operations group that provides administrative, technical and operational support; a statistical and data management center; and a network laboratory structure.

Why did NIAID restructure its HIV/AIDS clinical trials networks?

NIAID restructured its HIV/AIDS clinical trials networks to better address emerging domestic and international challenges to developing improved treatment and prevention strategies by creating a more integrated, collaborative and flexible research structure.

NIAID created its first HIV/AIDS clinical trials network in 1987 to develop and evaluate treatments for HIV-infected adults and children. As research on the disease expanded, additional networks were established to develop strategies for the prevention of HIV transmission and the optimization of clinical management of HIV-infected individuals. During the last two decades, each of the networks has made critical contributions in the fight against HIV/AIDS. However, as the HIV/AIDS pandemic has evolved, new scientific challenges and opportunities have arisen.

Planning for the restructuring began in October 2001 and included extensive consultations with researchers, clinicians, nurses, patient advocates and people living with, or at risk of, HIV/AIDS. The new networks are designed to capitalize on earlier HIV/AIDS medical advancements and foster further progress by expanding and strengthening research capacity, particularly in resource-limited countries, improving research efficiency through the shared use of key support services, and improving evaluation measures to ensure that the highest HIV/AIDS research priorities are addressed.

Who received the awards to lead the HIV/AIDS clinical trials networks?

NIAID has issued six awards for leadership of the restructured HIV/AIDS clinical trials networks. The following principal investigators and institutions have been selected to lead the networks:

• AIDS Clinical Trials Group (ACTG)—Constance A. Benson, M.D., University of California, San Diego
• HIV Prevention Trials Network (HPTN)—Sten Vermund, M.D., Ph.D., Vanderbilt University, Nashville
• HIV Vaccine Trials Network (HVTN)—Lawrence Corey, M.D., The Fred Hutchinson Cancer Research Center, Seattle
• International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT)—Jay Brooks Jackson, M.D., M.B.A., Johns Hopkins University School of Medicine, Baltimore
• International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)—James D. Neaton, Ph.D., University of Minnesota, Minneapolis
• Microbicide Trials Network (MTN)—Sharon Hillier, Ph.D., Magee-Womens Research Institute, Pittsburgh

What is the scientific focus of each the newly funded HIV/AIDS networks?

The networks will focus their efforts on one or more of NIAID’s six highest priorities in HIV/AIDS research, including

• Developing a safe and effective HIV vaccine
• Conducting translational research for new drug development
• Optimizing clinical management of HIV/AIDS, including co-infections and other HIV-related conditions
• Developing microbicides to prevent HIV acquisition and transmission
• Creating strategies to prevent mother-to-child HIV transmission
• Developing new methods of HIV prevention

The primary areas of research that will be conducted by each network are outlined below:

• ACTG: Optimizing clinical management of HIV/AIDS, including co-infections and other HIV-related conditions, and conducting translational research for new drug development
• HPTN: Evaluating non-vaccine HIV prevention strategies
• HVTN: Evaluating preventive HIV vaccines
• IMPAACT: (Focus on children, adolescents and pregnant women) Preventing mother-to-child transmission of HIV, optimizing clinical management of HIV/AIDS, including co-infections and other HIV-related conditions
• INSIGHT: Optimizing clinical management of HIV/AIDS, including co-infections and other HIV-related conditions
• MTN: Evaluating microbicides for HIV prevention

What is the role of the network leadership?

The leadership of each HIV/AIDS clinical trials network is responsible for planning, directing, coordinating and executing a research plan for one or more of the six HIV/AIDS research areas that NIAID has identified as high priority. The leadership must also ensure that its network has the internal capacity to implement the research plans and that the different components of each network collaborate efficiently and effectively to achieve the plans.

What is the amount of the NIAID leadership awards?

Total funding for both the network leadership and the clinical trials units (CTUs) is expected to reach $285 million during the first year of the awards.

Because the leadership awards represent the first of two sets of awards for the clinical trials networks, NIAID is issuing these awards with provisional funding.  Final budgets will be determined once the CTUs, which will carry out the networks’ research plans, are selected, funded and linked with a leadership group(s) to fully form the networks. That announcement is expected to be made by late 2006

What role will NIAID have with the newly funded networks?

The new networks will be funded as cooperative agreements within NIAID’s Division of AIDS. The Division of AIDS will work collaboratively with the network leaders to ensure that NIAID’s HIV/AIDS research priorities are being addressed in the most efficient and expedient manner possible.  In addition to resources, the Division of AIDS will provide oversight, research direction and will ensure that regulatory requirements are met.

What process did NIAID use to solicit applicants for the HIV/AIDS networks?

NIAID issued two separate but linked Request for Applications (RFAs) for the HIV/AIDS clinical trials networks; one to solicit network leadership and the other to solicit the CTUs. The RFA for the network leadership, which was issued in November 2004, was open to any domestic, public or private organization, including universities, colleges, hospitals, laboratories, division of state and local governments and eligible agencies of the U.S. federal government. The application deadline was May 11, 2005.

The RFA for the network CTUs was issued in February 2005 and closed July 11, 2005. NIAID expects to announce the CTU awardees by the end of calendar year 2006.

How did this RFA process differ from previous solicitations for HIV/AIDS clinical research networks?

Previous RFAs for NIAID-funded clinical research focused on separate areas of research, such as HIV treatment, prevention strategies or vaccines. This is the first time that a single RFA was issued seeking applications that encompassed a broad spectrum of HIV/AIDS clinical trials research in prioritized areas of research. The goal was to better integrate HIV prevention and treatment research and foster stronger collaboration among the clinical trials networks. 

How were the applications for Leadership for HIV/AIDS Clinical Trials Networks reviewed?

The six applications submitted in response to the Leadership for HIV/AIDS Clinical Trials Networks RFA received a scientific and technical merit peer review of their proposed clinical programs and were evaluated by NIAID for program relevance and the availability of funds. Six comparable Special Emphasis Panels (SEPS) were established with standards that included similar orientation sessions, some common members and a chairperson who participated on multiple SEPS. The scientific and technical merits of each application were discussed after separate reverse site visits during which applicants responded to reviewer questions.

The evaluation of the applications addressed scientific significance, approach, innovation, quality of potential investigators and environment and RFA-specific review criteria. Reviewers also examined the plans for protecting human research volunteers and for including women, minorities and children in research studies and the proposed budget.

The overall application received a priority score from 100 (best) to 500 (worst) based on RFA-specific review criteria and the quality of the application’s HIV/AIDS research and organizational structure plans.

Who served on the Special Emphasis Panels?

The members of the SEPS primarily were non-governmental employees, including clinical and laboratory investigators, primary care providers, research staff, and community representatives, public health experts; individuals with in-country experience and knowledgeable in working with racial/ethnic minorities; and fiscal experts.

What will happen to HIV/AIDS studies that are already under way in the previously funded networks?

Each of the HIV/AIDS network leadership applications included plans clearly delineating the continuation of ongoing clinical trials as well as studies planned for the future. Studies that are under way at the time of these awards will continue without interruption under the auspices of their current network or within the newly established network addressing the relevant area of research.

Will other NIH Institutes and Centers collaborate with these HIV/AIDS clinical trials networks?