Pharmacokinetics of Lopinavir/Ritonavir Superboosting in Infants and Young Children Co-infected With HIV and TB
NCT ID: NCT02348177
Last Updated: 2017-05-11
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
96 participants
Study Classification
INTERVENTIONAL
Study Start Date
2013-01-31
Study Completion Date
2016-12-31
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Acquired Immunodeficiency Syndrome
Tuberculosis
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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TB/HIV co-infection
Superboosting lopinavir with ritonavir in 1:1 ratio during TB/HIV co-infection and treatment of HIV with lopinavir/ritonavir 4:1
Group Type
EXPERIMENTAL
lopinavir with ritonavir in 1:1 ratio
Intervention Type
DRUG
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 4:1
Intervention Type
DRUG
This is the conventional dosing of LPV/r 4:1 for HIV when TB treatment has not been started or has been stopped
Interventions
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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
Intervention Type
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
Intervention Type
DRUG
Other Intervention Names
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Lopinavir/ritonavir
Ritonavir
Lopinavir/ritonavir
Eligibility Criteria
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Inclusion Criteria
* Documentation of a confirmed diagnosis of HIV-1 infection following SA clinical guidelines
* Weight \>3kg ≤15 kg at enrolment
* \> 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 RIF-based therapy
* Parent or legal guardian able and willing to provide written informed consent and able to attend study visits.
* Weight \>3kg ≤15 kg at enrolment
* \> 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 RIF-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.
* 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.
Minimum Eligible Age
2 Weeks
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Cape Town
OTHER
Sponsor Role
collaborator
Medecins Sans Frontieres, Netherlands
OTHER
Sponsor Role
collaborator
French Development Agency
OTHER_GOV
Sponsor Role
collaborator
UBS Optimus Foundation
OTHER
Sponsor Role
collaborator
Drugs for Neglected Diseases
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Mark Cotton, Professor
Role: PRINCIPAL_INVESTIGATOR
University of Stellenbosch
Locations
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The Children's Infectious Disease Clinical Research Unit; University of Stellenbosch
Cape Town, Western Cape, South Africa
Site Status
Enhancing Care Foundation; Wendworth Hospital
Durban, , South Africa
Site Status
Perinatal HIV Research Unit
Johannesburg, , South Africa
Site Status
Shandukani Research WRHI
Johannesburg, , South Africa
Site Status
Empilweni Services and Research Unit
Johannesburg, , South Africa
Site Status
Countries
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South Africa
References
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Zhang C, Denti P, Decloedt EH, Ren Y, Karlsson MO, McIlleron H. Model-based evaluation of the pharmacokinetic differences between adults and children for lopinavir and ritonavir in combination with rifampicin. Br J Clin Pharmacol. 2013 Nov;76(5):741-51. doi: 10.1111/bcp.12101.
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BACKGROUND
Galileya LT, Wasmann RE, Chabala C, Rabie H, Lee J, Njahira Mukui I, Hesseling A, Zar H, Aarnoutse R, Turkova A, Gibb D, Cotton MF, McIlleron H, Denti P. Evaluating pediatric tuberculosis dosing guidelines: A model-based individual data pooled analysis. PLoS Med. 2023 Nov 21;20(11):e1004303. doi: 10.1371/journal.pmed.1004303. eCollection 2023 Nov.
Reference Type
DERIVED
Rabie H, Tikiso T, Lee J, Fairlie L, Strehlau R, Bobat R, Liberty A, McIlleron H, Andrieux-Meyer I, Cotton M, Lallemant M, Denti P. Abacavir Exposure in Children Cotreated for Tuberculosis with Rifampin and Superboosted Lopinavir-Ritonavir. Antimicrob Agents Chemother. 2020 Apr 21;64(5):e01923-19. doi: 10.1128/AAC.01923-19. Print 2020 Apr 21.
Reference Type
DERIVED
Rabie H, Denti P, Lee J, Masango M, Coovadia A, Pillay S, Liberty A, Simon F, McIlleron H, Cotton MF, Lallemant M. Lopinavir-ritonavir super-boosting in young HIV-infected children on rifampicin-based tuberculosis therapy compared with lopinavir-ritonavir without rifampicin: a pharmacokinetic modelling and clinical study. Lancet HIV. 2018 Dec 6:S2352-3018(18)30293-5. doi: 10.1016/S2352-3018(18)30293-5. Online ahead of print.
Reference Type
DERIVED
Other Identifiers
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DNDiHIVPed001
Identifier Type: -
Identifier Source: org_study_id
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Safety, Tolerability, Drug Interactions, and Antiviral Activity of Rilpivirine in Antiretroviral-Naive HIV-Infected Children Less Than 12 Years of Age
NCT01975012
WITHDRAWN
PHASE1/PHASE2
A Study to Evaluate the Pharmacokinetics of Rilpivirine/Tenofovir/Emtricitabine After a Single-Oral Administration in Healthy Japanese Adult Male Participants
NCT02530060
COMPLETED
PHASE4
Pharmacokinetics and Safety Study of Tipranavir in Combination With Low Dose Ritonavir in Human Immunodeficiency Virus (HIV)-Infected Children
NCT00076999
COMPLETED
PHASE1
Emtricitabine Given Once A Day With Other Anti-HIV Drugs in Children With HIV
NCT00017992
UNKNOWN
PHASE2
The Effect of Intermittent Rifampicin on Raltegravir
NCT01424826
COMPLETED
PHASE1
Safety, Tolerability, and Blood Levels of Ritonavir-Boosted Atazanavir and Rifampin When Taken Together in HIV Uninfected Adults
NCT00096850
COMPLETED
NA
A Bioavailability Study of Rifabutin and Lopinavir/Ritonavir in Healthy Adult Subjects
NCT00743470
TERMINATED
PHASE1
A Study of Switching to RPV Plus Other ARVs in HIV-1-infected Children (Aged 2 to <12 Years) Who Are Virologically Suppressed
NCT04012931
COMPLETED
PHASE2
TMC125-TiDP2-C197: A Phase I Trial to Investigate the Pharmacokinetic Interaction Between Lopinavir/Ritonavir and TMC125 Both at Steady-state in Healthy Volunteers.
NCT00767117
COMPLETED
PHASE1
Pharmacokinetics of Once Daily Darunavir/Ritonavir in HIV-infected Children
NCT02285478
COMPLETED
The Raltegravir and Ribavirin Pharmacokinetics (PK) Study
NCT00982553
COMPLETED
PHASE1
Safety Study of Lopinavir/Ritonavir With Raltegravir in HIV-infected Patients
NCT00752037
COMPLETED
PHASE4
Effect of Rifabutin on the Pharmacokinetics of Oral Cabotegravir in Healthy Subjects
NCT03149848
COMPLETED
PHASE1
Study of Lopinavir/Ritonavir Tablets Versus Soft Gel Capsules and Once Daily Versus Twice Daily Administration, When Coadministered With Nucleoside Reverse Transcriptase Inhibitors in Antiretroviral Naive Human Immunodeficiency Virus Type 1 Infected Subjects
NCT00262522
COMPLETED
PHASE3
Pharmacokinetics of Generic Lopinavir/Ritonavir in Pregnant Women
NCT00621166
COMPLETED
PHASE2
Ritonavir-boosted Lopinavir Monotherapy
NCT01002898
COMPLETED
PHASE3
Abacavir and Lamivudine PK in Children
NCT01656122
COMPLETED
PHASE2/PHASE3