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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

NCT ID: NCT03847376

Last Updated: 2021-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

APPROVED_FOR_MARKETING

Study Classification

EXPANDED_ACCESS

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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JNJ-16150108-AAA

Eligibility Criteria

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Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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Janssen Sciences Ireland UC

INDUSTRY

Sponsor Role lead

ViiV Healthcare

INDUSTRY

Sponsor Role collaborator

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Sciences Ireland UC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Sciences Ireland UC

Other Identifiers

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TMC278LAHTX2001

Identifier Type: OTHER

Identifier Source: secondary_id

CR108331

Identifier Type: -

Identifier Source: org_study_id

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