Dolutegravir Study in HIV-1 Participants Completing IMPAACT Studies P1093 and P2019

PHASE3CompletedINTERVENTIONAL
Enrollment

101

Participants

Timeline

Start Date

June 7, 2017

Primary Completion Date

December 24, 2024

Study Completion Date

December 24, 2024

Conditions
HIV Infections
Interventions
DRUG

Dolutegravir film-coated tablets

Dolutegravir film-coated tablets will be provided as 50 mg tablets.

DRUG

Dolutegravir film-coated dispersible tablets

Dolutegravir film-coated dispersible tablets will be provided as 5 mg dispersible tablets. It will be administered at the appropriate dose as determined by results of the parent protocol to participants as per their age and weight band.

DRUG

ABC/DTG/3TC immediate release tablets

ABC/DTG/3TC immediate release tablets will be provided as biconvex, oval tablets containing 600 mg ABC, 50 mg DTG and 300 mg 3TC.

DRUG

ABC/DTG/3TC film-coated dispersible tablets

ABC/DTG/3TC dispersible tablets will be provided as biconvex, oval, film-coated tablets containing 60 mg ABC, 5 mg DTG and 30 mg 3TC.

Trial Locations (17)

1862

GSK Investigational Site, Soweto

2001

GSK Investigational Site, Johannesburg

3010

GSK Investigational Site, Moshi

4066

GSK Investigational Site, Umlazi

7505

GSK Investigational Site, Cape Town

10700

GSK Investigational Site, Bangkok

33316

GSK Investigational Site, Fort Lauderdale

50200

GSK Investigational Site, Chiang Mai

57000

GSK Investigational Site, Chiang Rai

90095

GSK Investigational Site, Los Angeles

38105-3678

GSK Investigational Site, Memphis

Unknown

GSK Investigational Site, Gaborone

GSK Investigational Site, Harare

30130-100

GSK Investigational Site, Belo Horizonte

26030-380

GSK Investigational Site, Nova Iguaçu

14048-900

GSK Investigational Site, RibeirAo PretoSP

21941-612

GSK Investigational Site, Rio de Janeiro

Sponsors

Lead Sponsor

All Listed Sponsors
lead

ViiV Healthcare

INDUSTRY

NCT03016533 - Dolutegravir Study in HIV-1 Participants Completing IMPAACT Studies P1093 and P2019 | Biotech Hunter | Biotech Hunter