Dolutegravir Pediatric Liquid Formulation Study

PHASE1CompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

May 7, 2019

Primary Completion Date

July 25, 2019

Study Completion Date

July 25, 2019

Conditions
HIV Infections
Interventions
DRUG

Dolutegravir dispersible tablet

DTG will be available as an oral tablet with dosing strength of 5 mg 2 tablet will be dispersed in water will be administered orally for prescribed regimen.

DRUG

Dolutegravir oral suspension

DTG will be available as an oral suspension with dosing strength of 5 mg per milliliter (ml) or 2 mg per ml with miglyol 812N or ethyl cellulose in miglyol 812N as vehicle for suspension administered orally for prescribed regimen.

DRUG

Dolutegravir oral solution

DTG will be available as an oral solution with dosing strength of 2 mg per ml will be administered orally for prescribed regimen.

Trial Locations (1)

NG11 6JS

GSK Investigational Site, Nottingham

Sponsors

Lead Sponsor

All Listed Sponsors
lead

ViiV Healthcare

INDUSTRY