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.
This is a multicentre, open label, non-randomized, prospective, noninferiority study to compare the pharmacokinetics of lopinavir administered with superboosting (LPV/r 1:1) and concurrent RIF treatment or with standard boosting (LPV/r 4:1) without concurrent RIF treatment, and to assess the safety, tolerance, and virological effect of superboosting in HIV-TB co-infected infants and children weighing \>3 kg and ≤15 kg. LPV/r will be administered as the liquid 80/20 mg/mL formulation (4:1 standard boosting ratio). During anti-TB treatment, additional RTV liquid formulation will be provided to deliver a 1:1 superboosting ratio of LPV to RTV. Actual doses for antiretrovirals and anti-TB drugs will be based on the South African (SA) weight band dosing recommendations and provided as per the site standard of care.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
96
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
This is the conventional dosing of LPV/r 4:1 for HIV when TB treatment has not been started or has been stopped
The Children's Infectious Disease Clinical Research Unit; University of Stellenbosch
Cape Town, Western Cape, South Africa
Enhancing Care Foundation; Wendworth Hospital
Durban, South Africa
Perinatal HIV Research Unit
Johannesburg, South Africa
Shandukani Research WRHI
Johannesburg, South Africa
Modelled C0/morning trough
Proportions of children treated with modelled lopinavir morning C0/morning trough \<1mg/L at each of the intensive PK evaluations.
Time frame: Predose
C0/morning trough
Proportions of children with observed lopinavir morning trough, C0/morning trough \<1mg/L at each of the intensive PK evaluations
Time frame: Predose
ALT
Safety and tolerability of superboosting focusing on liver functions through clinical and biochemical monitoring.
Time frame: baseline, PK1, PK2, PK3
ECG
Potential superboosting cardiac effect monitored by electrocardiogram at the beginning of anti-TB and HIV concomitant therapy
Time frame: baseline, 2 weeks after LPV/r 1:1, PK1
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Empilweni Services and Research Unit
Johannesburg, South Africa