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NCT05896748 · ClinicalTrials.gov registry record · Phase 3

Study to Assess the Effects of Cabotegravir (CAB) and Rilpivirine (RPV) Long-Acting (LA) Injections Following Sub-cutaneous (SC) Administration Compared With Intramuscular (IM) Administration in Adult Participants Living With Human Immunodeficiency Virus (HIV-1) Infection in the FLAIR Study

A Phase 3 study, sponsored by ViiV Healthcare.

Completed
Registry status
Phase 3
Development phase
94
Enrollment target

NCT05896748: Completed Phase 3 study, sponsored by ViiV Healthcare.

NCT05896748 is a Phase 3 study that has completed, run by ViiV Healthcare. The registered enrollment target is 94 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05896748, a Phase 3 study, has completed, sponsored by ViiV Healthcare.

COMPLETED
Registry status
Phase 3
Development phase
94 participants
Enrollment target

Study Summary

This study will assess the pharmacokinetics, safety, tolerability, maintenance of virological suppression and patient reported outcomes for participants receiving CAB and RPV LA injections following SC administration in the anterior abdominal wall SC tissue compared with IM administration in the gluteus medius muscle in adult participants living with HIV-1 infection in the FLAIR study (NCT02938520).

Primary Outcome

Blood samples were collected at indicated time points for PK analysis.

Interventions

  • DRUG Cabotegravir - Injectable Suspension (CAB LA)
  • DRUG Rilpivirine - Injectable Suspension (RPV LA)

Trial Details

FieldValue
Enrollment Target 94 participants
Start Date 2022-11-08
Est. Completion 2023-09-14
Phase Phase 3
ViiV Healthcare

182 total trials

What the finished NCT05896748 record still lists

NCT05896748 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 94 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower).

The record links to 0 conditions, and to 2 interventions - of which Cabotegravir - Injectable Suspension (CAB LA) is the first listed.

NCT05896748 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05896748 about?

NCT05896748 is a clinical study titled "Study to Assess the Effects of Cabotegravir (CAB) and Rilpivirine (RPV) Long-Acting (LA) Injections Following Sub-cutaneous (SC) Administration Compared With Intramuscular (IM) Administration in Adult Participants Living With Human Immunodeficiency Virus (HIV-1) Infection in the FLAIR Study". This study will assess the pharmacokinetics, safety, tolerability, maintenance of virological suppression and patient reported outcomes for participants receiving CAB and RPV LA injections following SC administration in the anterior abdominal wall SC tissue compared with IM administration in the glu...

What is the current status of trial NCT05896748?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 94 participants. The study started on 2022-11-08. Estimated completion is 2023-09-14.

What interventions are being tested in trial NCT05896748?

The interventions under investigation include: Cabotegravir - Injectable Suspension (CAB LA) (DRUG), Rilpivirine - Injectable Suspension (RPV LA) (DRUG).

Who is sponsoring clinical trial NCT05896748?

This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05896748's enrollment target sits among peer trials

94 1719th of 2000 higher than 279 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05896748, the US trial registry maintained by the National Library of Medicine. NCT05896748 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.