Trials / Approved For Marketing
Approved For MarketingNCT03847376
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
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Janssen Sciences Ireland UC · Industry
- Sex
- —
- Age
- —
- Healthy volunteers
- —
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- First posted
- 2019-02-20
- Last updated
- 2021-04-05
Source: ClinicalTrials.gov record NCT03847376. Inclusion in this directory is not an endorsement.