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

NCT03847376 | Unknown

• 2 other identifiers: CR108331TMC278LAHTX2001
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

HIV

Keywords

Rilpivirine; Long Acting Rilpivirine Injection; HIV; Rilpivirine Expanded Access; Rilpivirine Single Patient Request

Interventions

Rilpivirine Long Acting (RPV LA) DRUG

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.

Also known as: JNJ-16150108-AAA

Sponsors & Collaborators

• Janssen Sciences Ireland UC: lead
• ViiV Healthcare: collaborator

Study Officials

• Janssen Sciences Ireland UC Clinical Trial

  Janssen Sciences Ireland UC

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2019
• First Posted: February 20, 2019
• Last Updated: April 5, 2021

Record last verified: 2021-03