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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

171

Participants

Timeline

Start Date

July 28, 2023

Primary Completion Date

September 3, 2025

Study Completion Date

September 3, 2026

Conditions
HIV Infections
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.

Trial Locations (47)

1405

GSK Investigational Site, Ciudad Autonoma de Bueno

20127

GSK Investigational Site, Milan

20157

GSK Investigational Site, Milan

20246

GSK Investigational Site, Hamburg

28007

GSK Investigational Site, Madrid

28031

GSK Investigational Site, Madrid

28078

GSK Investigational Site, Huntersville

28204

GSK Investigational Site, Charlotte

29010

GSK Investigational Site, Málaga

30008

GSK Investigational Site, Murcia

32504

GSK Investigational Site, Pensacola

32804

GSK Investigational Site, Orlando

33308

GSK Investigational Site, Fort Lauderdale

34982

GSK Investigational Site, Ft. Pierce

35010

GSK Investigational Site, La Laguna-Tenerife

35016

GSK Investigational Site, Granada

35205

GSK Investigational Site, Birmingham

40225

GSK Investigational Site, Düsseldorf

41071

GSK Investigational Site, Seville

45067

GSK Investigational Site, Orléans

48072

GSK Investigational Site, Berkley

60329

GSK Investigational Site, Frankfurt am Main

64111

GSK Investigational Site, Kansas City

68198

GSK Investigational Site, Omaha

71100

GSK Investigational Site, Foggia

75004

GSK Investigational Site, Paris

75015

GSK Investigational Site, Paris

75246

GSK Investigational Site, Dallas

75475

GSK Investigational Site, Paris

76104

GSK Investigational Site, Fort Worth

77701

GSK Investigational Site, Beaumont

80337

GSK Investigational Site, München

89106

GSK Investigational Site, Henderson

93301

GSK Investigational Site, Bakersfield

94000

GSK Investigational Site, Créteil

4780000

GSK Investigational Site, Temuco

7500000

GSK Investigational Site, Providencia

7970000

GSK Investigational Site, La Cisterna

9500000

GSK Investigational Site, Santiago

C1202

GSK Investigational Site, Buenos Aires

B7600DHK

GSK Investigational Site, Mar del Plata

S2013

GSK Investigational Site, Rosario

L8S 1A4

GSK Investigational Site, Hamilton

H2L 4P9

GSK Investigational Site, Montreal

00149

GSK Investigational Site, Roma

00717-1563

GSK Investigational Site, Ponce

04009

GSK Investigational Site, Almería

Sponsors
All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

collaborator

PPD Development, LP

INDUSTRY

lead

ViiV Healthcare

INDUSTRY