Opportunity Information: Apply for RFA CA 19 056
The Limited Competition: AIDS Malignancy Consortium (AMC) (UM1 Clinical Trials Required) funding opportunity (RFA-CA-19-056) is a National Institutes of Health (NIH) cooperative agreement designed to continue support for the AIDS Malignancy Consortium, a long-standing, multi-site clinical trials network focused on cancers that occur in people with HIV. The core idea behind this program is to maintain and strengthen a shared national infrastructure that can rapidly design and run cooperative clinical studies, especially where single institutions would struggle to enroll enough participants or assemble the specialized expertise needed to answer clinically important questions. Because this is a UM1 cooperative agreement, NIH is not simply providing funds and stepping back; it signals substantial programmatic involvement, coordination, and partnership between the funded consortium and NIH staff, with an expectation that the program will actively conduct clinical trials rather than only planning or observational work.
The AMC infrastructure is intended to stimulate and support collaborative research in several connected areas. First, it prioritizes the design, development, and evaluation of clinical interventions aimed at preventing and treating HIV-associated malignancies, meaning trials may include preventive approaches, new therapeutic regimens, and strategies to reduce cancer-related complications in people living with HIV. Second, it emphasizes developing more effective therapeutics and management strategies for HIV-associated cancers, which can include optimizing standard oncology treatments in the context of HIV, addressing drug-drug interactions between anticancer agents and antiretroviral therapy, and tailoring supportive care to the needs of immunocompromised or medically complex patients. Third, the FOA highlights investigation of the biology of HIV-related malignancies within the context of clinical trials, which points to an integrated approach where correlative science, tumor biology, immune profiling, and other translational endpoints are embedded into clinical studies to help explain why certain treatments work, fail, or cause toxicity in this population. Fourth, the AMC is expected to address issues of international importance in HIV-associated malignancies, recognizing that HIV and cancer burdens and care delivery challenges vary across settings; however, the eligibility and component rules mean the core applicant structure must remain U.S.-based even if some work has foreign components as permitted by NIH policy. Finally, the consortium must support the distribution of excess tumor tissue and other relevant biological fluids to the AIDS and Cancer Specimen Resource, ensuring that valuable specimens collected during trials are banked and shared for future research, thereby extending the scientific value of each enrolled participant and each completed study.
Structurally, the announcement requires the AMC to include several functional units that collectively make the consortium operational. A Coordination Center is expected to handle day-to-day network management, protocol activation logistics, communication, regulatory coordination across sites, and overall operational harmonization so studies can be launched and run efficiently. Clinical Trial Sites are the front line for participant recruitment, informed consent, treatment administration, clinical assessments, safety reporting, and retention, and they are crucial for enrolling diverse populations and ensuring adherence to Good Clinical Practice. Network Laboratories provide essential scientific and technical capabilities that support both routine clinical trial needs and higher-value translational research, including assay work for correlative and pathogenesis-driven studies. These laboratories are also specifically expected to support clinical pharmacology and pharmacokinetics studies related to anticancer and antiviral interactions, a key issue in HIV oncology where drug metabolism, overlapping toxicities, and interaction risks can substantially affect outcomes. A Statistical Center is required to provide rigorous study design, randomization and data monitoring support when relevant, interim and final analyses, data quality oversight, and methodological expertise to ensure that trial results are credible and interpretable, especially in rare cancers or special populations where sample sizes can be limited and endpoints must be carefully chosen.
Scientifically, the consortium must maintain at least four disease-oriented working groups, which signals an organized, expert-led approach to prioritizing and advancing research across major HIV-associated cancer areas. The required working groups include Kaposi sarcoma, lymphoma, human papillomavirus (HPV)-associated cancers, and non-AIDS-defining cancers. This lineup reflects both historically prominent AIDS-associated cancers and the evolving cancer landscape among people with HIV, where effective antiretroviral therapy has changed incidence patterns and increased attention to malignancies not traditionally classified as AIDS-defining. These working groups are generally expected to drive protocol concepts, refine research questions, coordinate subject-matter expertise, and ensure that trial portfolios remain clinically relevant and scientifically current.
The FOA also includes an explicit expectation around equitable access and inclusivity: all clinical trials conducted by the AMC must be available to subjects of all racial and ethnic groups. In practice, this pushes the network to design recruitment strategies, site selections, eligibility criteria, and retention plans that do not inadvertently exclude underrepresented groups, and to ensure that trial participation opportunities are broadly accessible. This requirement aligns with longstanding NIH priorities on inclusion and also reflects the reality that HIV and certain cancers disproportionately affect particular communities, making representativeness a scientific and ethical necessity.
In terms of administrative details from the source information provided, the opportunity is categorized as discretionary funding and uses the cooperative agreement mechanism. It sits within NIH health-related activity areas and is associated with CFDA numbers 93.393, 93.394, 93.395, and 93.396. The listed eligible applicants include public and state-controlled institutions of higher education, and the eligibility statements clarify that non-U.S. entities (foreign institutions) are not eligible to apply and that non-U.S. components of U.S. organizations are not eligible to apply, while foreign components as defined by the NIH Grants Policy Statement are allowed, which typically means limited, well-justified portions of work may occur outside the U.S. under a U.S. applicant’s award when permitted and properly documented. The original closing date shown is January 10, 2020, and the opportunity was created on September 11, 2019. Taken together, the announcement is essentially about sustaining a robust, multi-component national clinical trials network dedicated to improving prevention and treatment of HIV-associated cancers while embedding high-quality translational science, specimen sharing, and coordinated operations across specialized sites and laboratories.Apply for RFA CA 19 056
- The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Limited Competition: AIDS Malignancy Consortium (AMC) (UM1 Clinical Trials Required)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.393, 93.394, 93.395, 93.396.
- This funding opportunity was created on 2019-09-11.
- Applicants must submit their applications by 2020-01-10. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Public and State controlled institutions of higher education.
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Frequently Asked Questions (FAQs): Limited Competition: AIDS Malignancy Consortium (AMC) (UM1 Clinical Trials Required) - RFA-CA-19-056
What is this funding opportunity?
This opportunity, titled "Limited Competition: AIDS Malignancy Consortium (AMC) (UM1 Clinical Trials Required)" (RFA-CA-19-056), is a National Institutes of Health (NIH) cooperative agreement intended to continue support for the AIDS Malignancy Consortium (AMC), a long-standing, multi-site clinical trials network focused on cancers that occur in people with HIV.
What is the main purpose of continuing the AMC?
The purpose is to maintain and strengthen a shared national infrastructure that can rapidly design and run cooperative clinical studies in HIV-associated malignancies. The network structure is intended to make it feasible to conduct trials that single institutions may not be able to run on their own due to challenges like limited participant availability or the need for specialized expertise.
What does "UM1" mean in this context?
UM1 is the cooperative agreement mechanism used for this program. It indicates that NIH is not only providing funding, but is also expected to have substantial programmatic involvement, coordination, and partnership with the funded consortium.
What does "Clinical Trials Required" imply for the program?
"Clinical Trials Required" means the funded consortium is expected to actively conduct clinical trials. The program is not limited to planning activities or observational research; it is designed to support the execution of clinical intervention studies.
What kinds of research does the AMC infrastructure prioritize?
Based on the information provided, AMC-supported work prioritizes: (1) clinical interventions to prevent and treat HIV-associated malignancies, (2) development of more effective therapeutics and management strategies for HIV-associated cancers, (3) investigation of the biology of HIV-related malignancies within the context of clinical trials (for example, embedding translational and correlative endpoints), (4) issues of international importance in HIV-associated malignancies (as permitted by NIH policy), and (5) distribution of excess tumor tissue and biological fluids to the AIDS and Cancer Specimen Resource.
What is meant by "clinical interventions" for HIV-associated malignancies?
Clinical interventions may include preventive approaches, new therapeutic regimens, and strategies to reduce cancer-related complications in people living with HIV, as evaluated through cooperative clinical studies.
How does the program address drug-drug interactions for people with HIV and cancer?
The opportunity highlights the need to optimize oncology treatments in the context of HIV, including addressing drug-drug interactions between anticancer agents and antiretroviral therapy. Network Laboratories are specifically expected to support clinical pharmacology and pharmacokinetics studies related to anticancer and antiviral interactions.
How is translational or correlative science incorporated?
The FOA emphasizes investigating the biology of HIV-related malignancies within clinical trials. This points to integrating tumor biology, immune profiling, correlative science, and other translational endpoints into clinical studies to help explain treatment response, failure, and toxicity in people with HIV.
Does the program include any expectations for international relevance?
Yes. The consortium is expected to address issues of international importance in HIV-associated malignancies. At the same time, the applicant structure must remain U.S.-based, and any foreign components must fit within NIH policy as described in the eligibility statements provided.
What are the required components of the AIDS Malignancy Consortium under this announcement?
The AMC is required to include several functional units: a Coordination Center, Clinical Trial Sites, Network Laboratories, and a Statistical Center. Together, these units are intended to make the consortium operational and capable of efficiently launching and running clinical trials.
What is the role of the Coordination Center?
The Coordination Center is expected to manage day-to-day network operations, including protocol activation logistics, communication, regulatory coordination across sites, and overall operational harmonization to support efficient study launch and conduct.
What is the role of the Clinical Trial Sites?
Clinical Trial Sites are responsible for participant recruitment, informed consent, treatment administration, clinical assessments, safety reporting, and retention. They are central to enrolling diverse populations and ensuring adherence to Good Clinical Practice.
What is the role of the Network Laboratories?
Network Laboratories provide scientific and technical capabilities that support routine clinical trial needs and translational research, including assays for correlative and pathogenesis-driven studies. They are also expected to support clinical pharmacology and pharmacokinetics work related to interactions between anticancer and antiviral therapies.
What is the role of the Statistical Center?
The Statistical Center is required to support rigorous study design, randomization and data monitoring support when relevant, interim and final analyses, and data quality oversight. Its purpose is to ensure trial results are credible and interpretable, including in settings where sample sizes may be limited.
Are there specific scientific areas the consortium must cover?
Yes. The consortium must maintain at least four disease-oriented working groups: Kaposi sarcoma, lymphoma, HPV-associated cancers, and non-AIDS-defining cancers.
Why are these particular working groups required?
The listed working groups reflect both historically prominent AIDS-associated cancers (such as Kaposi sarcoma and certain lymphomas) and the evolving cancer landscape among people with HIV, including HPV-associated cancers and non-AIDS-defining cancers.
What do the disease-oriented working groups do?
These working groups are generally expected to drive protocol concepts, refine research questions, coordinate subject-matter expertise, and help keep the consortium's trial portfolio clinically relevant and scientifically current.
Is there an inclusion or equity requirement for AMC trials?
Yes. All clinical trials conducted by the AMC must be available to subjects of all racial and ethnic groups. This implies that recruitment strategies, site selection, eligibility criteria, and retention plans should support broad access and avoid unintended exclusion of underrepresented groups.
What is required regarding biospecimens collected during trials?
The consortium must support the distribution of excess tumor tissue and other relevant biological fluids to the AIDS and Cancer Specimen Resource. This is intended to ensure specimens are banked and shared for future research, extending the scientific value of each trial and enrolled participant.
What type of funding is this categorized as?
The opportunity is categorized as discretionary funding and uses the cooperative agreement mechanism.
Which agency is offering this opportunity?
The opportunity is offered through the National Institutes of Health (NIH).
What are the CFDA numbers associated with this opportunity?
The associated CFDA numbers listed are 93.393, 93.394, 93.395, and 93.396.
Who is eligible to apply based on the information provided?
Eligible applicants include public and state-controlled institutions of higher education.
Are non-U.S. (foreign) institutions eligible to apply?
No. The eligibility statements provided indicate that non-U.S. entities (foreign institutions) are not eligible to apply.
Are non-U.S. components of U.S. organizations eligible to apply?
No. The eligibility information provided states that non-U.S. components of U.S. organizations are not eligible to apply.
Are foreign components allowed in any form?
Yes. Foreign components, as defined by the NIH Grants Policy Statement, are allowed. This typically means limited, well-justified parts of the work may occur outside the U.S. under a U.S.-based applicant's award when permitted and properly documented.
What is the listed closing date for this opportunity?
The original closing date shown is January 10, 2020.
When was this opportunity created?
The opportunity was created on September 11, 2019.
What makes a cooperative clinical trials network necessary for this field?
The program description emphasizes that cooperative infrastructure helps address practical barriers such as difficulty enrolling enough participants at a single institution and the need for specialized, coordinated expertise to answer clinically important questions in HIV-associated cancers.
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