HIV Drug Development—In Vivo Efficacy Evaluations

This service provides evaluation of products in animal efficacy models. A product must demonstrate a potent and selective activity profile in vitro against the HIV strain used in the model prior to its acceptance as a candidate for this service. Studies to determine optimal routes and schedules of drug administration can be performed.

Main Areas of Focus

  • To fill specific gaps in an investigator’s HIV drug development plan as they advance their product toward clinical investigation
  • To help investigators obtain data to get additional funding
  • To attract prospective partners
  • To support regulatory submissions

Support Services

  • Evaluation of HIV therapy or cure strategies in immunodeficient mice implanted with human tissues
  • HIV-1 strains commonly used in the model are NL4-3 (CXCR4-tropic) and Ba-L (CCR5-tropic)
  • Antiviral efficacy is demonstrated by a reduction in virus load (p24 and RNA) and protection of the implanted human cells from virus-induced depletion
  • Evaluation of the product’s toxicity to the implanted tissue is performed prior to an antiviral efficacy study

Investigators seeking these services receive no funding from NIAID, but instead receive products or information generated by NIAID-funded contractors on their behalf.

Who Can Use This Resource

  • Investigators must be conducting HIV research.
  • Compounds must previously have been successfully synthesized or produced.
  • Investigators must have preliminary data to support the continued development of the product.
  • Product must demonstrate a potent and selective activity profile in vitro against HIV.

How To Get Started

  • Follow the procedures for requesting access to NIAID contract services.
  • In addition, data packages for In Vivo Efficacy Evaluations may address the following items:
    • In vitro efficacy profile against HIV
    • Experience formulating product (and placebo) for animal use
    • Drug stability in solution
    • Knowledge of in vivo metabolite formation
    • Data from animal studies that might help guide dose selection and route and frequency of administration