RecruitingPhase 3NCT06694805

A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1

A Phase 3b, Open Label, Randomized, standard-of Care Control Arm, Multicenter, Superiority Study Evaluating the Efficacy, Safety, and Tolerability of Injectable CAB LA + RPV LA in Viremic Participants Living With HIV-1 (CROWN)


Sponsor

ViiV Healthcare

Enrollment

332 participants

Start Date

Dec 2, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study will assess how effective, safe, and long-lasting a long-acting antiretroviral therapy (ART) using CAB LA + RPV LA is for people with HIV who still have detectable virus levels despite being on oral ART. The study will also consider feedback from patients on their experience with this treatment.


Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating long-acting injectable HIV treatment — a combination of cabotegravir and rilpivirine given as injections every 1–2 months — in HIV-positive individuals whose current oral medication is not adequately controlling the virus. Rather than taking daily pills, participants would receive monthly or bi-monthly injections. **You may be eligible if...** - You are 12 years or older and weigh at least 35 kg - You have confirmed HIV-1 infection - Your HIV viral load is between 1,000 and 100,000 copies/mL (indicating the virus is not fully suppressed) - Your current oral HIV medication has not been working well enough — either not reducing virus levels, or you have been unable to take it consistently - You are currently on an oral HIV treatment regimen and willing to continue it until around Month 6 **You may NOT be eligible if...** - Your viral load is very high (above 100,000 copies/mL) or very low (below 1,000) - You have HIV that is resistant to the study drugs - You have serious organ problems that would interfere with the medications - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCAB LA + RPV LA

Intramuscular injection administered monthly for first 2 initiation doses then every 2 months.

DRUGOral ART

Oral medication provided to participants by the site/their regular healthcare professional (HCP) as part of their standard of care (SOC) treatment.


Locations(89)

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Beverly Hills, California, United States

GSK Investigational Site

Los Angeles, California, United States

GSK Investigational Site

Los Angeles, California, United States

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Los Angeles, California, United States

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Aurora, Colorado, United States

GSK Investigational Site

Denver, Colorado, United States

GSK Investigational Site

New Haven, Connecticut, United States

GSK Investigational Site

Newark, Delaware, United States

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Washington D.C., District of Columbia, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Sarasota, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

GSK Investigational Site

Decatur, Georgia, United States

GSK Investigational Site

Macon, Georgia, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Baltimore, Maryland, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Berkley, Michigan, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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Newark, New Jersey, United States

GSK Investigational Site

Hawthorne, New York, United States

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New York, New York, United States

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New York, New York, United States

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The Bronx, New York, United States

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The Bronx, New York, United States

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Greensboro, North Carolina, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Philadelphia, Pennsylvania, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Seattle, Washington, United States

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Milwaukee, Wisconsin, United States

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Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Capital Federal, Argentina

GSK Investigational Site

Ciudad Autonoma de Bueno, Argentina

GSK Investigational Site

Córdoba, Argentina

GSK Investigational Site

Rosario, Argentina

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Antwerp, Belgium

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Ottawa, Ontario, Canada

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Montreal, Quebec, Canada

GSK Investigational Site

Montreal, Quebec, Canada

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Cologne, North Rhine-Westphalia, Germany

GSK Investigational Site

Berlin, Germany

GSK Investigational Site

Cologne, Germany

GSK Investigational Site

Düsseldorf, Germany

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Frankfurt, Germany

GSK Investigational Site

Bari, Italy

GSK Investigational Site

Bergamo, Italy

GSK Investigational Site

Milan, Italy

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Milan, Italy

GSK Investigational Site

Roma, Italy

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Porto, Portugal

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Porto, Portugal

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San Juan, Puerto Rico

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Bilbao, Spain

GSK Investigational Site

Cadiz, Spain

GSK Investigational Site

Córdoba, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Málaga, Spain

GSK Investigational Site

Málaga, Spain

GSK Investigational Site

Murcia, Spain

GSK Investigational Site

Palma de Mallorca, Spain

GSK Investigational Site

Sabadell Barcelona, Spain

GSK Investigational Site

Seville, Spain

GSK Investigational Site

Vigo Pontevedra, Spain

GSK Investigational Site

Zaragoza, Spain

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NCT06694805


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