564 Participants NeededMy employer runs this trial

Cabotegravir + Rilpivirine for HIV Infection

Recruiting at 65 trial locations
Age: Any Age
Sex: Any
Trial Phase: Phase 3
Sponsor: ViiV Healthcare
Must be taking: Antiretrovirals
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This study compares the efficacy, safety and tolerability of CAB ULA and RPV ULA administered with CAB long acting (LA) and RPV LA administered in adults and adolescents with HIV who are virologically suppressed on anti-retroviral therapy (ART).

Are You a Good Fit for This Trial?

This trial is for people aged 12 and older with HIV who have had very low virus levels (undetectable) for at least a year, are currently taking daily HIV meds without recent treatment failure, and weigh over 35 kg.

Inclusion Criteria

I have only changed HIV treatment for reasons other than treatment failure.
I am 12 or older, weigh over 35 kg, and have HIV-1 infection.
My HIV-1 levels have been under 50 copies/mL in the past year.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CAB ULA+RPV ULA or CAB LA+RPV LA

23 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Trial Overview

The study compares two long-acting injectable combinations—CAB ULA plus RPV ULA versus CAB LA plus RPV LA—in adults and teens with well-controlled HIV to see which works better and is safer.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: CAB ULA+ RPV ULAExperimental Treatment2 Interventions
Group II: CAB LA+ RPV LAActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

ViiV Healthcare

Lead Sponsor

Trials
379
Recruited
479,000+
Founded
2009
Headquarters
London, England, UK
Known For
HIV Research
Top Products
- Tivicay (dolutegravir), - Triumeq (abacavir/dolutegravir/lamivudine), - Juluca (dolutegravir/rilpivirine), - Apretude (cabotegravir)
Dr. Harmony Garges profile image

Dr. Harmony Garges

ViiV Healthcare

Chief Medical Officer

MD

Deborah Waterhouse profile image

Deborah Waterhouse

ViiV Healthcare

Chief Executive Officer since 2017

Bachelor's degree in Business Administration