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PSR

ViiV Healthcare Pure Substance Request (PSR)

Purpose and Scope:ViiV Healthcare (VH) Pure Substances are available as “in kind” donations for preclinical research (in vitro or animal) to study novel disease biology and advance scientific knowledge within the HIV cure and remission space. At this time, these requests pertain to active pharmaceutical ingredient (API)/pure substance for Dolutegravir and Cabotegravir. This does not include long-acting formulations of the product.

Out of Scope:

  • Commercial product or discovery requests.
  • In vitro or animal studies that fall outside of the remit of cure and remission and/or include a request for funding should be submitted directly from the VH Investigator Sponsored Study overview page.
  • In vitro or animal studies that fall outside of the remit of cure and remission and/or include a request for funding or wish to collaborate with VH should be submitted directly from the VH Collaborative Study overview page.

Registration: To fully utilize this site, you must first register a profile. Once registered, you will be able to:

  • Submit a full study proposal on the provided template into VH’s PSR system for review.
  • Submit required documents.
  • Check the status of both proposals and previously approved studies.
  • Make updates to ongoing studies supported by ViiV.
  • Post and receive electronic documentation directly through the system.
  • Receive periodic prompts regarding key milestones and deliverables (conference presentations and publications) associated with your proposals or previously approved studies.

Decision Timeline: Decisions on pure drug substance requests will be communicated within 4-6 weeks of the proposal submission of all required documents in this portal.

  • If ViiV decides to support the request with an in-kind donation of the pure substance, a standard non-negotiable MTA will be sent for partial execution. Once fully executed, the drug will be shipped within one to two weeks.
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All Safety Reporting must be conducted as per your study agreement. If you need to report a suspected side effect for a ViiV Healthcare medicine that is not part of your study, please click the following.

Report a side effect

To report a suspected side effect, please use the online reporting form below. This facility is provided under our service agreement with GlaxoSmithKline (GSK), so please choose ‘ViiV Healthcare medicines’ from the drop-down product list on the form. In North America, you can report a side effect via the GSK Response Center at 1-888-825-5249, Monday-Friday, 8am - 8pm ET.

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