Pharmacokinetics of Lopinavir/Ritonavir Superboosting in Infants and Young Children Co-infected With HIV and TB

PHASE4CompletedINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

January 31, 2013

Primary Completion Date

December 31, 2016

Study Completion Date

December 31, 2016

Conditions
Acquired Immunodeficiency SyndromeTuberculosis
Interventions
DRUG

lopinavir with ritonavir in 1:1 ratio

During co-treatment of rifampicin containing tuberculosis treatment and lopinavir/ritonavir (4:1) based therapy, additional ritonavir is given to make lopinavir/ritonavir 1:1 ratio

DRUG

Lopinavir/ritonavir 4:1

This is the conventional dosing of LPV/r 4:1 for HIV when TB treatment has not been started or has been stopped

Trial Locations (5)

1864

Perinatal HIV Research Unit, Johannesburg

2001

Shandukani Research WRHI, Johannesburg

2093

Empilweni Services and Research Unit, Johannesburg

4013

Enhancing Care Foundation; Wendworth Hospital, Durban

7505

The Children's Infectious Disease Clinical Research Unit; University of Stellenbosch, Cape Town

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

University of Cape Town

OTHER

collaborator

Medecins Sans Frontieres, Netherlands

OTHER

collaborator

French Development Agency

OTHER_GOV

collaborator

UBS Optimus Foundation

OTHER

lead

Drugs for Neglected Diseases

OTHER