Official Title
Rilpivirine Long Acting Single Patient Requests
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.

Approved for marketing
Individual Patients

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.
Other Name: JNJ-16150108-AAA

Janssen Sciences Ireland UC Clinical Trial
Study Director
Janssen Sciences Ireland UC

Janssen Sciences Ireland UC
ViiV Healthcare
NCT Number
Long Acting Rilpivirine Injection
Rilpivirine Expanded Access
Rilpivirine Single Patient Request
MeSH Terms