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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

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ClinicalTrials.gov Identifier: NCT03847376
Expanded Access Status : Approved for marketing
First Posted : February 20, 2019
Last Update Posted : April 5, 2021
Sponsor:
Collaborator:
ViiV Healthcare
Information provided by (Responsible Party):
Janssen Sciences Ireland UC

Study Description
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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.

Condition or disease Intervention/treatment
HIV Drug: Rilpivirine Long Acting (RPV LA)

Study Design
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Study Type : Expanded Access
Expanded Access Type : Individual Patients
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Rilpivirine Long Acting Single Patient Requests

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Rilpivirine

Interventions
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Intervention Details:
  • 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
Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03847376


Sponsors and Collaborators
Janssen Sciences Ireland UC
ViiV Healthcare
Investigators
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Study Director: Janssen Sciences Ireland UC Clinical Trial Janssen Sciences Ireland UC
More Information
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Responsible Party: Janssen Sciences Ireland UC
ClinicalTrials.gov Identifier: NCT03847376    
Other Study ID Numbers: CR108331
TMC278LAHTX2001 ( Other Identifier: Janssen Sciences Ireland UC )
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: April 5, 2021
Last Verified: March 2021
Keywords provided by Janssen Sciences Ireland UC:
Rilpivirine
Long Acting Rilpivirine Injection
HIV
Rilpivirine Expanded Access
Rilpivirine Single Patient Request
Additional relevant MeSH terms:
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Rilpivirine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Anti-Retroviral Agents