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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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PACTR |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
PACTR201302000426554 |
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Date of registration:
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04/10/2012 |
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Primary sponsor: |
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Public title:
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Pharmacokinetics of lopinavir/ritonavir superboosting in infants and young children co-infected with HIV and TB
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Scientific title:
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An open label, sequential non-randomised pharmacokinetics study comparing lopinavir plasma exposure when given as lopinavir superboosted with ritonavir (1:1 ratio) in the presence of rifampicin or lopinavir boosted with ritonavir (4:1 ratio) in the absence of rifampicin in HIV and TB co-infected children in South Africa |
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Date of first enrolment:
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2012-12-01 |
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Target sample size:
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90 |
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Recruitment status: |
Not yet recruiting |
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URL:
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HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201302000426554 |
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Study type:
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interventional |
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Study design:
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Single group: all participants receive same intervention throughout study,
Non-randomised,
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Countries of recruitment
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South Africa
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Contacts
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Name:
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Marc
Lallemant |
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Address:
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Drugs for Neglected Diseases Initiative, 15 Chemin Louis Dunant
1202
Geneva
Switzerland |
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Telephone:
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+41 79 293 1205 |
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Email:
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mlallemant@dndi.org |
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Affiliation:
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Head of Paediatric HIV Program |
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Name:
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Marc
Lallemant |
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Address:
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Drugs for Neglected Diseases initiative, 15 Chemin Louis Dunant
1202
Geneva
Switzerland |
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Telephone:
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+41 79 293 1205 |
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Email:
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mlallemant@dndi.org |
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Affiliation:
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Head of Paediatric HIV Program |
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Key inclusion & exclusion criteria
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Inclusion criteria: Documentation of a confirmed diagnosis of HIV-1 infection following SA clinical guidelines
Weight b3kg and `/=15 kg at enrolment
b 42 weeks gestational age
On LPV/r-based therapy or about to start a LPV/r-based antiretroviral combination therapy with 2 NRTIs [ABC+3TC or AZT+3TC or d4T+3TC]
Clinical diagnosis of TB requiring rifampicin-based therapy
Parent or legal guardian able and willing to provide written informed consent and able to attend study visits.
Exclusion criteria: For neonates, less than 42 weeks gestation and 14 days old
Concomitant/chronic treatment with potent enzyme-inducing/inhibiting drugs other than those in the study treatments . See Appendix E (minor inducers/inhibitors and drugs used as part of management of the condition are allowed eg. Steroids)
Anticipation at the start that anti-TB treatment duration will be longer than 9 months
Any other condition/finding that, in the investigator?s opinion, would compromise the child?s participation in this study eg. alanine transferase (ALT) more than 10 times upper limit of normal (ULN), or chronic renal, hepatic or gastrointestinal disease such as malabsorption.
Children with known malignancies and contraindications to taking LPV/r
Treatment with experimental drugs for any indication within 30 days prior to study entry; participation in another study may be approved by the study team.
Age minimum:
2 Week
Age maximum:
5 Year
Gender:
Both
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Health Condition(s) or Problem(s) studied
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HIV/AIDS
Tuberculosis
null
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Primary Outcome(s)
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To demonstrate that the proportion of subjects achieving LPV C0/morning trough above 1mg/L during superboosting of LPV with RTV (in a 1:1 ratio) while on RIF-based anti-TB treatment, is not inferior the proportion of subjects achieving LPV C0/morning trough above 1 mg/L during ART with LPV/r (in a 4:1 ratio) in the absence of anti-TB treatment
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Secondary Outcome(s)
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Compare the model-based estimates of the LPV PK measures of exposure (C0/morning trough, C12/evening trough, Cmax, AUC) during anti-TB treatment and superboosting vs. during treatment with standard LPV/r doses 1 month after completing TB therapy.
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To assess adherence to therapy
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To assess the safety and tolerability of LPV/r liquid formulation in HIV-infected infants and children with RTV superboosting (1:1 ratio LPV/r) with concomitant RIF-based anti-TB treatment.
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To compare abacavir (ABC) blood levels during and after co-treatment with rifampicin based anti-TB therapy
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To describe viral load evolution before, during and after superboosting and monitor resistance in children failing therapy
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To determine the pharmacokinetics of anti-TB drugs concomitantly administered with superboosted PI.
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To explore the effects of age, weight, sex, initial severity of tuberculosis and anthropometric measurements on LPV & RTV pharmacokinetics, i.e. exposure, C12/evening trough, Cmax and C0/morning trough concentrations with/without concomitant anti-TB treatment.
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Source(s) of Monetary Support
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M?decins Sans Fronti?res - Norway
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