Pre-Approval Access to Rilpivirine Long Acting (RPV LA) Injectable Suspension for the Treatment of a Participant With Human Immunodeficiency Virus (HIV)-1 Infection

Overview

The main purpose of this pre-approval access program (PAAP) is to provide rilpivirine Long Acting (RPV LA) injectable suspension for the treatment of human immunodeficiency virus (HIV)-1 infection as single patient request to individuals who have no available treatment alternatives and/or limited treatment options (for example, who are unable to participate in the Phase III clinical studies or do not qualify). RPV LA can only be provided if participants are also eligible for cabotegravir Long Acting injections.

Full Title of Study: “Rilpivirine Long Acting Single Patient Requests”

Study Type

  • Study Type: Expanded Access

Interventions

  • Drug: Rilpivirine Long Acting (RPV LA)
    • Participants will receive RPV LA injectable suspension containing 300 milligram per milliliter (mg/mL) of RPV by intramuscular (IM) injection. A starting dose of 900 milligram (mg) RPV LA (3 milliliter [mL] suspension) will be administered with subsequent doses of 600 mg RPV given at 4-week intervals.

Investigator Details

  • Lead Sponsor
    • Janssen Sciences Ireland UC
  • Collaborator
    • ViiV Healthcare
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Janssen Sciences Ireland UC Clinical Trial, Study Director, Janssen Sciences Ireland UC

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