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

Rilpivirine Long Acting Single Patient Requests

Status
APPROVED_FOR_MARKETING
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT03847376
Enrollment
Unknown
Registered
2019-02-20
Start date
Unknown
Completion date
Unknown
Last updated
2021-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Keywords

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

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.

Interventions

DRUGRilpivirine 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.

Sponsors

ViiV Healthcare
CollaboratorINDUSTRY
Janssen Sciences Ireland UC
Lead SponsorINDUSTRY

Eligibility

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026