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NCT03847376 Clinical Trial

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

HIV Clinical Trial

Official title:
Rilpivirine Long Acting Single Patient Requests

Clinical Trial Details — Status: Approved for marketing

Administrative data
NCT number NCT03847376
Other study ID # CR108331
Secondary ID TMC278LAHTX2001
Status Approved for marketing
Phase
First received
Last updated

Study information
Verified date March 2021
Source Janssen Sciences Ireland UC
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

Recruitment information / eligibility

— Not specified —

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Janssen Sciences Ireland UC ViiV Healthcare
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