HIVNCT03847376

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

A study testing Rilpivirine Long Acting (RPV LA) in people with HIV, run by Janssen Sciences Ireland UC.

Approved For Marketing

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: HIV
What is being tested?: Rilpivirine Long Acting (RPV LA)
Type of treatment: Injection or infusion
How many people: Not given
Where: No sites listed yet
Study dates: Start not givento not given
Phase: Expanded access
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
Child, Adult, Older adult

About this study

Official title: Rilpivirine Long Acting Single Patient Requests

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: HIV
Being tested: Rilpivirine Long Acting (RPV LA)
Keywords: Rilpivirine, Long Acting Rilpivirine Injection, HIV, Rilpivirine Expanded Access, Rilpivirine Single Patient Request

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Rilpivirine Long Acting (RPV LA)Drug
Also called JNJ-16150108-AAA
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

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

First posted20 Feb 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HIVStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Expanded access

IDs, dates and publications

ClinicalTrials.gov ID: NCT03847376
Sponsor's protocol ID: CR108331
Other IDs: TMC278LAHTX2001
Status last verified: Mar 2021
First submitted: 18 Feb 2019
Last updated: 5 Apr 2021
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Rilpivirine Long Acting Single Patient Requests
ClinicalTrials.gov ID: NCT03847376
Acronym / sponsor ID: CR108331
Conditions: HIV
Keywords: Rilpivirine, Long Acting Rilpivirine Injection, HIV, Rilpivirine Expanded Access, Rilpivirine Single Patient Request
Study type: Expanded access
Recruitment status: Approved For Marketing
Lead sponsor: Janssen Sciences Ireland UCIndustry (pharma, biotech, devices)
Collaborators: ViiV Healthcare
First posted: 20 Feb 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Who may qualify

Age groups: Child, Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Rilpivirine Long Acting (RPV LA)Also: JNJ-16150108-AAAParticipants 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.	Drug	–

Primary outcome

Not reported in the source record.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2021.

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Gabapentin to Reduce Alcohol and Improve Viral Load Suppression
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Janssen Sciences Ireland UC Clinical Trial study director

Janssen Sciences Ireland UC

Questions about this trial

What is this clinical trial studying?

A study testing Rilpivirine Long Acting (RPV LA) in people with HIV, run by Janssen Sciences Ireland UC.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03847376.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2021; AzTrials last refreshed its copy on 6 Nov 2026.