CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 96 enrolled
Drug / intervention
lopinavir with ritonavir in 1:1 ratio +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02348177
NCT02348177Phase 4Completed
CompareCT.gov

A Pharmacokinetics Study Comparing Lopinavir Plasma Exposure When Given as Lopinavir/Ritonavir (1:1) in the Presence of Rifampicin and Lopinavir/Ritonavir (4:1) Without Rifampicin in HIV and TB Co-infected Children in South Africa.

Drugs for Neglected Diseases·interventional·Posted Jan 28, 2015·Updated May 11, 2017

In Brief

A Phase 4 clinical trial evaluating lopinavir with ritonavir in 1:1 ratio and Lopinavir/ritonavir 4:1 for Acquired Immunodeficiency Syndrome and Tuberculosis. Completed, enrolled 96 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcquired Immunodeficiency Syndrome, Tuberculosis
CountriesSouth Africa
CollaboratorsUniversity of Cape Town, Medecins Sans Frontieres, Netherlands, French Development Agency, UBS Optimus Foundation

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 28, 2015
Enrollment StartJan 1, 2013
Primary CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 11.4 years ago

Interventions

lopinavir with ritonavir in 1:1 ratiodrug

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

Lopinavir/ritonavir 4:1drug

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