A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral Therapy

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

481

Participants

Timeline

Start Date

February 9, 2024

Primary Completion Date

March 24, 2026

Study Completion Date

February 23, 2027

Conditions
HIVHIV Infections
Interventions
DRUG

Dolutegravir

Dolutegravir will be administered once daily.

DRUG

Lamivudine

Lamivudine will be administered once daily.

DRUG

Bictegravir

Bictegravir will be administered once daily.

DRUG

Emtricitabine

Emtricitabine will be administered once daily.

DRUG

Tenofovir alafenamide

Tenofovir alafenamide will be administered once daily.

Trial Locations (65)

7

GSK Investigational Site, Dublin

1000

GSK Investigational Site, Brussels

2000

GSK Investigational Site, Antwerp

2650

GSK Investigational Site, Hvidovre

4031

GSK Investigational Site, Basel

7198

GSK Investigational Site, Palma de Mallorca

8005

GSK Investigational Site, Zurich

9000

GSK Investigational Site, Ghent

10787

GSK Investigational Site, Berlin

20146

GSK Investigational Site, Hamburg

24127

GSK Investigational Site, Bergamo

27100

GSK Investigational Site, Pavia

28040

GSK Investigational Site, Madrid

28041

GSK Investigational Site, Madrid

28046

GSK Investigational Site, Madrid

29603

GSK Investigational Site, Marbella

30029

GSK Investigational Site, Nîmes

31059

GSK Investigational Site, Lyon

31096

GSK Investigational Site, Haifa

33000

GSK Investigational Site, Bordeaux

33076

GSK Investigational Site, Bordeaux

34090

GSK Investigational Site, Montpellier

35010

GSK Investigational Site, La Laguna-Tenerife

35128

GSK Investigational Site, Padua

45170

GSK Investigational Site, Zapopan

46014

GSK Investigational Site, Valencia

50668

GSK Investigational Site, Cologne

52621

GSK Investigational Site, Ramat Gan

54635

GSK Investigational Site, Thessaloniki

60590

GSK Investigational Site, Frankfurt

64239

GSK Investigational Site, Tel Aviv

70124

GSK Investigational Site, Bari

75012

GSK Investigational Site, Paris

75013

GSK Investigational Site, Paris

75018

GSK Investigational Site, Paris

75970

GSK Investigational Site, Paris

76100

GSK Investigational Site, Rehovot

80336

GSK Investigational Site, München

97070

GSK Investigational Site, Mérida

C1425AWK

GSK Investigational Site, Ciudad Autonoma de Buenos Aire

X5000JJS

GSK Investigational Site, Córdoba

06202

GSK Investigational Site, Nice

106 76

GSK Investigational Site, Athens

11 527

GSK Investigational Site, Athens

D09 V2N0

GSK Investigational Site, Dublin

07100

GSK Investigational Site, Sassari

460-0001

GSK Investigational Site, Aichi

540-0006

GSK Investigational Site, Osaka

108-8639

GSK Investigational Site, Tokyo

162-8655

GSK Investigational Site, Tokyo

85-030

GSK Investigational Site, Bydgoszcz

91-347

GSK Investigational Site, Lodz

50-136

GSK Investigational Site, Wroclaw

3814-501

GSK Investigational Site, Aveiro

4099-001

GSK Investigational Site, Porto

08916

GSK Investigational Site, Badalona

08036

GSK Investigational Site, Barcelona

03203

GSK Investigational Site, Elche Alicante

07120

GSK Investigational Site, Palma de Mallorca

SE-14186

GSK Investigational Site, Stockholm

G12 OYN

GSK Investigational Site, Glasgow

E9 6SR

GSK Investigational Site, London

SE5 8AF

GSK Investigational Site, London

W1D 6AQ

GSK Investigational Site, London

W2 1NY

GSK Investigational Site, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

ViiV Healthcare

INDUSTRY