Limited Competition: AIDS Malignancy Consortium (AMC) (UM1 Clinical Trials Required) | RFA CA 19 056

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.

• 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.

Apply for RFA CA 19 056

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