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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
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
DTG/3TC
DTG/3TC FDC will be administered as an oral once daily tablet.
Cabotegravir (CAB) LA
CAB LA will be administered as a gluteal intramuscular injection once every 2 months in combination with RPV LA.
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