A Phase 4 interventional study of lopinavir with ritonavir in 1:1 ratio and Lopinavir/ritonavir 4:1 in Acquired Immunodeficiency Syndrome and Tuberculosis, sponsored by Drugs for Neglected Diseases. Completed at 5 sites in South Africa. Open to participants aged 2 Weeks and older. Per ClinicalTrials.gov, last updated 2017-05-11.
Sponsored by Drugs for Neglected Diseases · Phase 4, Interventional, and Treatment
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.
2,099 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 273 are open to participants now.
This study's enrollment of 96 is close to the median of 104 across 1,590 interventional studies indexed under Acquired Immunodeficiency Syndrome.
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Superboosting lopinavir with ritonavir in 1:1 ratio during TB/HIV co-infection and treatment of HIV with lopinavir/ritonavir 4:1
Drug: lopinavir with ritonavir in 1:1 ratio · Drug: Lopinavir/ritonavir 4:1
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
Also known as: Lopinavir/ritonavir, Ritonavir
This is the conventional dosing of LPV/r 4:1 for HIV when TB treatment has not been started or has been stopped
Also known as: Lopinavir/ritonavir
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
The record gives a start of Jan 2013, a primary completion of Dec 2016 and a completion of Dec 2016. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome →
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