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

NCT02348177 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2017-05-11

No results posted yet for this study

Summary

The purpose of this study is to determine the lopinavir levels in blood of HIV and TB infected children (3-15kg) when given lopinavir/ritonavir in a 1:1 ratio with rifampicin containing TB regimen and its safety.

Conditions

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

Sponsors & Collaborators

  • University of Cape Town

    collaborator OTHER

  • Medecins Sans Frontieres, Netherlands

    collaborator OTHER

  • French Development Agency

    collaborator OTHER_GOV

  • UBS Optimus Foundation

    collaborator OTHER

  • Drugs for Neglected Diseases

    lead OTHER

Principal Investigators

  • Mark Cotton, Professor · University of Stellenbosch

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02348177 on ClinicalTrials.gov