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Integrase Inhibitor

Participants receiving CAB LA + RPV LA for HIV

Phase 3

Waitlist Available

Research Sponsored by ViiV Healthcare

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 4: pre-dose; week 8: pre-dose and week 12: pre-dose

Awards & highlights

Study Summary

This trial tests a new way to give HIV meds that could be safer & more effective.

Eligible Conditions

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 4: pre-dose; week 8: pre-dose and week 12: pre-dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 4: pre-dose; week 8: pre-dose and week 12: pre-dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 4: pre-dose; week 8: pre-dose and week 12: pre-dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

AUC(0-tau) of CAB LA and RPV LA following administration of IM injection

Area under the plasma concentration-time curve (AUC[0-tau]) of CAB LA and RPV LA following administration of SC injection

Cmax of CAB LA and RPV LA following administration of IM injection

+3 more

Secondary outcome measures

Change From Baseline in Total Treatment Satisfaction Score using HIV Treatment Satisfaction Status Questionnaire (HIVTSQs) Following Administration of SC Injection (scores on a scale)

Change From Baseline in Total Treatment Satisfaction Score using HIVTSQs Following Administration of IM Injection (scores on a scale)

Change From Baseline in individual item scores using HIVTSQc Following Administration of SC Injection (scores on a scale)

+33 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Participants receiving CAB LA + RPV LAExperimental Treatment2 Interventions

Participants will receive SC abdominal injection of CAB LA and RPV LA on Day 1 of every 4 weeks for a total of 12 weeks during the SC abdominal injection phase and will return to the clinic 4 weeks later to receive their first IM gluteal injections (at Week 12) of CAB LA and RPV LA during the return to gluteal injection phase. Subsequent gluteal injection with CAB LA and RPV LA will occur 4 weeks later for 4 weeks later at Week 16.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rilpivirine - Injectable Suspension (RPV LA)

2022

Completed Phase 3

~100

Cabotegravir - Injectable Suspension (CAB LA)

2022

Completed Phase 3

~100

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

ViiV HealthcareLead Sponsor

359 Previous Clinical Trials

468,450 Total Patients Enrolled

Janssen PharmaceuticalsIndustry Sponsor

80 Previous Clinical Trials

204,978 Total Patients Enrolled

GlaxoSmithKlineIndustry Sponsor

4,750 Previous Clinical Trials

8,067,359 Total Patients Enrolled

Media Library

Cabotegravir (Integrase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05896748 — Phase 3

HIV Research Study Groups: Participants receiving CAB LA + RPV LA

HIV Clinical Trial 2023: Cabotegravir Highlights & Side Effects. Trial Name: NCT05896748 — Phase 3

Cabotegravir (Integrase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05896748 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How extensively is this clinical trial being conducted across North American medical facilities?

"To ensure patient convenience, this medical trial is being held at 26 sites around the United States. These locations range from Austin to Bellaire and Dallas. Consequently, prospective participants are encouraged to join a nearby centre in order to reduce traveling demands."

Answered by AI

To what extent can individuals be impacted by CAB LA + RPV LA?

"As this clinical trial is in its third stage, our team at Power has determined that CAB LA + RPV LA carries a safety rating of 3 due to the existing data which supports both effectiveness and safety."

Answered by AI

Are any new participants being sought for this clinical experiment?

"As per the information hosted on clinicaltrials.gov, this medical experiment is not currently accepting applicants. This specific trial was posted on November 8th 2022 and edited as recently as May 31st 2023; however, there are 517 other research projects in need of volunteers at present time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05896748.