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ACTIVE NOT RECRUITING
NCT05917509
PHASE3

A Study to Evaluate the Efficacy, Safety, Participant Choice and Preference of an Oral Once-daily Regimen or a Long-acting Injectable Regimen Every Two Months for Treatment of Human Immunodeficiency Virus (HIV-1) in Adults Who Have Not Previously Taken Antiretroviral Therapy

Sponsor: ViiV Healthcare

View on ClinicalTrials.gov

Summary

This is a multicentre study carried out in participants living with human immunodeficiency virus type 1 (HIV-1) who have not previously been treated with any antiretroviral therapies. The study will investigate two 2-drug regimens for the treatment of HIV-1: a fixed-dose combination oral tablet of dolutegravir/lamivudine (DTG/3TC) and cabotegravir plus rilpivirine long-acting agents (CAB + RPV LA). All participants will initially receive DTG/3TC once daily, and once virologic suppression is attained (plasma HIV-1 \<50 c/mL), participants will be offered a choice to switch to CAB + RPV LA or to continue taking oral DTG/3TC. This study will provide important data on the efficacy, safety, implementation effectiveness, and patient-reported outcomes of these two regimens in a study where participants have the option to choose between them based on individual preference. The aim of the study is to evaluate the antiviral effectiveness at 11 months after switching to CAB+RPV LA following initial virologic suppression on DTG/3TC and to provide data on how long it takes participants to suppress their viral load on DTG/3TC.

Official title: A Phase IIIb, Multi-center, Non-randomized, Parallel-group, Open-label, Hybrid Type I Study Evaluating the Efficacy, Safety, Implementation Effectiveness, and Patient-reported Outcomes of Oral Dolutegravir/Lamivudine Once-daily as a First-line Regimen Followed by Participant-determined Optional Switch to Long-acting Intramuscular Cabotegravir Plus Rilpivirine Every Two Months for the Maintenance of Virologic Suppression in Antiretroviral Therapy Naive Adults Living With HIV-1

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

171

Start Date

2023-07-06

Completion Date

2026-04-22

Last Updated

2026-03-09

Healthy Volunteers

No

Conditions

Interventions

DRUG

DTG/3TC

DTG/3TC FDC will be administered as an oral once daily tablet.

DRUG

Cabotegravir (CAB) LA

CAB LA will be administered as a gluteal intramuscular injection once every 2 months in combination with RPV LA.

DRUG

Rilpivirine (RPV) LA

RPV LA will be administered as a gluteal intramuscular injection once every 2 months in combination with CAB LA.

Locations (47)

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Bakersfield, California, United States

GSK Investigational Site

Fort Lauderdale, Florida, United States

GSK Investigational Site

Ft. Pierce, Florida, United States

GSK Investigational Site

Orlando, Florida, United States

GSK Investigational Site

Pensacola, Florida, United States

GSK Investigational Site

Berkley, Michigan, United States

GSK Investigational Site

Kansas City, Missouri, United States

GSK Investigational Site

Omaha, Nebraska, United States

GSK Investigational Site

Henderson, Nevada, United States

GSK Investigational Site

Charlotte, North Carolina, United States

GSK Investigational Site

Huntersville, North Carolina, United States

GSK Investigational Site

Beaumont, Texas, United States

GSK Investigational Site

Dallas, Texas, United States

GSK Investigational Site

Fort Worth, Texas, United States

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Ciudad Autonoma de Bueno, Argentina

GSK Investigational Site

Mar del Plata, Argentina

GSK Investigational Site

Rosario, Argentina

GSK Investigational Site

Hamilton, Ontario, Canada

GSK Investigational Site

Montreal, Quebec, Canada

GSK Investigational Site

La Cisterna, Chile

GSK Investigational Site

Providencia, Chile

GSK Investigational Site

Santiago, Chile

GSK Investigational Site

Temuco, Chile

GSK Investigational Site

Créteil, France

GSK Investigational Site

Orléans, France

GSK Investigational Site

Paris, France

GSK Investigational Site

Paris, France

GSK Investigational Site

Paris, France

GSK Investigational Site

Düsseldorf, Germany

GSK Investigational Site

Frankfurt am Main, Germany

GSK Investigational Site

Hamburg, Germany

GSK Investigational Site

München, Germany

GSK Investigational Site

Foggia, Italy

GSK Investigational Site

Milan, Italy

GSK Investigational Site

Milan, Italy

GSK Investigational Site

Roma, Italy

GSK Investigational Site

Ponce, Puerto Rico

GSK Investigational Site

Almería, Spain

GSK Investigational Site

Granada, Spain

GSK Investigational Site

La Laguna-Tenerife, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Málaga, Spain

GSK Investigational Site

Murcia, Spain

GSK Investigational Site

Seville, Spain