Lopinavir/r/ Lamivudine/ Abacavir as an Easy to Use Paediatric Formulation

PHASE1/PHASE2UnknownINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

June 4, 2019

Primary Completion Date

November 30, 2019

Study Completion Date

December 31, 2019

Conditions
HIV
Interventions
DRUG

ABC/3TC/LPV/r granules (30/15/40/10 mgs)

"This is a fixed dose combination. Each capsule contains Lopinavir (40mg), Ritonavir (10mg), Abacavir (30mg) and Lamivudine (15mg) in granules formulation.~Dosage according to patient's weight:~Between 3 and 5.9kg: 2 capsules twice a day Between 6 and 9.9kg: 3 capsules twice a day Between 10 and 13.9kg: 4 capsules twice a day Between 14 and 19.9kg: 5 capsules twice a day Between 20 and 24.9kg: 6 capsules twice a day"

DRUG

LPV/r Pellets (40/10mgs) plus ABC/3TC (60/30mgs)

"Lopinavir/Ritonavir (40/10mg pellets) plus dual Abacavir/Lamivudine (60/30mg dispersible tablets)~Dosage according to patient's weight:~LPV/r Pellets:~Between 3 and 5.9kg: 2 capsules twice a day Between 6 and 9.9kg: 3 capsules twice a day Between 10 and 13.9kg: 4 capsules twice a day Between 14 and 19.9kg: 5 capsules twice a day Between 20 and 24.9kg: 6 capsules twice a day~ABC/3TC:~Between 3 and 5.9kg: 1 tablet twice a day Between 6 and 9.9kg: 1.5 tablets twice a day Between 10 and 13.9kg: 2 tablets twice a day Between 14 and 19.9kg: 2.5 tablets twice a day Between 20 and 24.9kg: 3 tablets twice a day"

Trial Locations (3)

Unknown

RECRUITING

Baylor College of Medicine Children's Foundation Uganda, Kampala

RECRUITING

Joint Clinical research Centre, Kampala

RECRUITING

Epicentre Mbarara Research Centre, Mbarara

All Listed Sponsors
collaborator

UNITAID

OTHER

collaborator

AMS-PHPT Research Platform (Program for HIV Prevention and Treatment)

UNKNOWN

collaborator

Joint Clinical Research Centre- Kampala

UNKNOWN

collaborator

Baylor College of Medicine Childrens Foundation, Uganda

UNKNOWN

collaborator

Epcentre Centre Mbarara Research Centre

UNKNOWN

collaborator

Institute of Tropical Medicine, Belgium

OTHER

lead

Drugs for Neglected Diseases

OTHER