Develop Long-Acting Treatments for HIV and HIV-Associated Co-Infections

Funding News Edition: April 15, 2020
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NIAID seeks applications proposing research on long-acting therapeutics for HIV-associated tuberculosis (TB), HIV, hepatitis B virus (HBV), and hepatitis C virus (HCV) through the new funding opportunity announcement (FOA) Long-Acting Treatments for HIV and HIV-Associated Co-Infections (R61/R33, Clinical Trial Not Allowed).

The FOA also supports projects developing novel safe and effective oral, injectable, implantable, or transdermal drug products with a patient administration goal of once monthly or less, along with those discovering and developing new active pharmaceutical ingredients (APIs) from the classes of small molecular peptides.

Structure of the Phased Award

Your proposed project must include milestone-driven, phased research activities with investigator-provided milestones. NIAID will provide support for up to three years for the R61 phase and two years for the R33 phase.

Before the end of the R61 phase, NIH program staff will evaluate the grantee’s R33 transition package and make transition decisions based on successful milestone completion, program priorities, and availability of funding. For more information, see our Phased Award SOP.

Responsive Areas of Research

Although the preferred dosing frequency is once per month or longer, NIAID will accept applications that propose weekly or biweekly administration. We also encourage innovative discovery, drug delivery platforms, and nonclinical product development activities.

For HIV—applications should focus on discovering new long-acting antiretrovirals and developing new molecules from existing classes of antiretrovirals for potential use as long-acting agents.

For TB and Hepatitis B or C—propose to either develop new long-acting/extended release formulations of existing drugs for treating TB or viral hepatitis B or C; or discover and develop new compounds as long-acting agents.

See the following for examples of responsive research:

  • Discovery, through chemical synthesis, of new APIs that exhibit highly potent and selective in-vitro activity against HIV, HBV, HCV, or Mycobacterium tuberculosis (Mtb)
  • Identification and further development of existing APIs with established activity against HIV, HBV, HCV, or Mtb and resistance patterns
  • In-vitro and in-vivo studies to evaluate the potential toxicity and safety of selected APIs and drug products
  • In silico tools, i.e., computational absorbance distribution, absorption, distribution, metabolism, excretion, and PK modeling tools may be used in drug product design
  • Medicinal chemistry and lead optimization studies
  • Use of appropriate animal disease models for efficacy evaluations
  • In-vitro and in-vivo studies to determine resistance profile of potential drug products for HIV, TB, and hepatitis B and C indications
  • Pharmacological studies of candidate products in laboratory animals to assess drug levels in plasma and local cellular and target tissues, and characterize the pharmacological profile and in-vivo product release
  • Drug to drug interaction studies
  • Pre-formulation studies that include chemical and physical characterization of the selected API and drug products. This might include performing U.S. Pharmacopeia Convention-compliant stability and drug release testing.

Nonresponsive Areas of Research

If you propose the following research areas, NIAID will consider your application nonresponsive and not review it:

  • Further development of the marketed antiretroviral drugs as long-acting agents. In pursuit of such research programs, refer instead to the FOA Sustained Release of Antivirals for Treatment or Prevention of HIV (SRATP) (R01, Clinical Trial Not Allowed).
  • Random or bulk screening of chemical or natural product libraries or collections to "discover" candidate molecules, including development of an uncharacterized natural product consisting of a complex mixture of potentially active and inactive ingredients
  • Developing broadly neutralizing antibodies or non-neutralizing antibodies as long-acting agents
  • Strategies for HIV, TB, or HBV vaccines
  • Applications focused on products other than small molecules or peptides
  • Clinical trials

Deadline, Budget, and Contact Information

NIAID intends to fund three to five awards. Application budgets are not limited but need to reflect the actual needs of the project. The maximum project period is five years.

Applications are due July 28, 2020, by 5 p.m. local time of the applicant organization.

Direct all questions to Dr. Marina Protopopova, NIAID’s scientific/research contact.

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