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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 : Available
First Posted : February 20, 2019
Last Update Posted : February 20, 2019
Sponsor:
Collaborator:
ViiV Healthcare
Information provided by (Responsible Party):
Janssen Sciences Ireland UC

Tracking Information
First Submitted Date February 18, 2019
First Posted Date February 20, 2019
Last Update Posted Date February 20, 2019
 
Descriptive Information
Brief Title Pre-Approval Access to Rilpivirine Long Acting (RPV LA) Injectable Suspension for the Treatment of a Participant With Human Immunodeficiency Virus (HIV)-1 Infection
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.
Detailed Description Not Provided
Study Type Expanded Access
Expanded Access Type Individual Patients
Condition HIV
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.
Other Name: JNJ-16150108-AAA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status Available
Eligibility Criteria Not Provided
Sex/Gender Not Provided
Ages Child, Adult, Older Adult
Contacts
Contact: Contact 1-800-JANSSEN (1-800-526-7736) Janssenmedinfo@its.jnj.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03847376
Other Study ID Numbers CR108331
TMC278LAHTX2001 ( Other Identifier: Janssen Sciences Ireland UC )
Responsible Party Janssen Sciences Ireland UC
Study Sponsor Janssen Sciences Ireland UC
Collaborators ViiV Healthcare
Investigators
Study Director: Janssen Sciences Ireland UC Clinical Trial Janssen Sciences Ireland UC
PRS Account Janssen Sciences Ireland UC
Verification Date February 2019