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Integrase Inhibitor, Non-Nucleoside Reverse Transcriptase Inhibitor

CAB LA for Human Immunodeficiency Virus Infection

Phase 2

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 up to month 17

Awards & highlights

Study Summary

This trial will study the effects of an experimental antiviral drug given as an injection every two months, in people who have HIV and are already taking other antiviral medications. The trial will last until the drug regimen receives regulatory approval and becomes commercially available, and will enroll approximately 100 participants.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to month 17

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to month 17

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to month 17 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Percentage of Participants With HIV-ribonucleic Acid (RNA) >=50 Copies Per Milliliter (c/mL) as Per Food and Drug Administration (FDA) Snapshot Algorithm at Month 12

Secondary outcome measures

Absolute Values for CD4+ for DTG + RPV Arm

Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm

Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm

+53 more

Other outcome measures

Ctrough for RPV LA

Plasma Trough Concentration (Ctrough) for CAB LA

Trial Design

2Treatment groups

Experimental Treatment

Group I: Participants receiving Oral DTG plus RPVExperimental Treatment2 Interventions

The eligible participants in the arm (participants from LATTE, who were administered oral CAB 30 mg plus RPV 25 mg, who successfully complete Week 300) will receive their first dose of the DTG 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants will continue to receive the treatment until the study intervention is locally approved and commercially available.

Group II: Participants receiving Injection CAB LA plus RPV LAExperimental Treatment2 Interventions

The eligible participants in the arm (participants from LATTE, who were administered oral CAB 30 mg plus RPV 25 mg, who successfully complete Week 300) will receive their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections will be administered 1 month after initial loading dose (CAB LA 600 mg plus RPV LA 900 mg), with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants will continue to receive the treatment until the study intervention is locally approved and commercially available. HAART therapy will be initiated within 8 weeks after the last Q2M injection.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

RPV LA

2018

Completed Phase 3

~540

CAB LA

2018

Completed Phase 3

~650

RPV

2014

Completed Phase 2

~530

DTG

2018

Completed Phase 3

~2530

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

ViiV HealthcareLead Sponsor

359 Previous Clinical Trials

468,446 Total Patients Enrolled

Janssen, LPIndustry Sponsor

159 Previous Clinical Trials

307,343 Total Patients Enrolled

GSK Clinical TrialsStudy DirectorViiV Healthcare

3,595 Previous Clinical Trials

6,143,833 Total Patients Enrolled

Frequently Asked Questions

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

Has the FDA greenlit RPV for therapeutic use?

"While there is some evidence backing RPV's safety, as this is a Phase 2 trial, there is no data currently supporting its efficacy. Therefore, it received a score of 2."

Answered by AI

How many total facilities are overseeing this clinical trial?

"This study, which is currently recruiting from 26 different sites, is mostly based in the southern United States. A few of these locations include Las Vegas, Macon and Savannah. If you are selected for this trial, it would be ideal if you lived near one of these centres to reduce travel time and costs."

Answered by AI

Are patients being enrolled in this research project at this time?

"This particular clinical trial is not recruiting patients at the moment, as seen on clinicaltrials.gov. This study was first posted on 8/20/2018 and has since been updated on 10/24/2022. However, out of the 499 other trials similar to this one, there are many that are still actively recruiting participants."

Answered by AI

Recent research and studies

AidsJournal

Long-acting Cabotegravir and Rilpivirine for HIV-1 Suppression: Switch to 2-monthly Dosing After 5 Years of Daily Oral Therapy

Mills, Anthony, Gary J. Richmond, Cheryl Newman, Olayemi Osiyemi, Jerry Cade, Cynthia Brinson, Jerome De Vente, et al.. 2021. “Long-acting Cabotegravir and Rilpivirine for HIV-1 Suppression: Switch to 2-monthly Dosing After 5 Years of Daily Oral Therapy”. Aids. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/qad.0000000000003085.

clinicaltrials.govStudy

Phase 2b, Open-label, Multicenter, Rollover Study to Assess Antiviral Activity and Safety of Long-acting (LA) Cabotegravir (CAB) Plus LA Rilpivirine (RPV), Administered Every 2 Months (Q2M), in Human Immunodeficiency Virus (HIV)-Positive Participants From the LATTE Study

2018. "Phase 2b, Open-label, Multicenter, Rollover Study to Assess Antiviral Activity and Safety of Long-acting (LA) Cabotegravir (CAB) Plus LA Rilpivirine (RPV), Administered Every 2 Months (Q2M), in Human Immunodeficiency Virus (HIV)-Positive Participants From the LATTE Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03639311.