Pharmacokinetics of Lopinavir/Ritonavir Superboosting in Infants and Young Children Co-infected With HIV and TB

NCT02348177 | Completed Phase 4 DMC

• 1 other identifier: DNDiHIVPed001
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Acquired Immunodeficiency Syndrome; Tuberculosis

Keywords

Human immunideficiency virus; Tuberculosis; superboosting; lopinavir/ritonavir 1:1; Pediatric TB/HIV co-infection

Outcome Measures

Primary Outcomes (1)

• Modelled C0/morning trough

  Proportions of children treated with modelled lopinavir morning C0/morning trough \<1mg/L at each of the intensive PK evaluations.

  Predose

Secondary Outcomes (3)

• C0/morning trough

  Predose

• ALT

  baseline, PK1, PK2, PK3

• ECG

  baseline, 2 weeks after LPV/r 1:1, PK1

Study Arms (1)

TB/HIV co-infection

EXPERIMENTAL

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

Interventions

lopinavir with ritonavir in 1:1 ratio 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

Also known as: Lopinavir/ritonavir, Ritonavir

TB/HIV co-infection

Lopinavir/ritonavir 4:1 DRUG

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

TB/HIV co-infection

Eligibility Criteria

• Age: 2 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Drugs for Neglected Diseases: lead
• University of Cape Town: collaborator
• Medecins Sans Frontieres, Netherlands: collaborator
• French Development Agency: collaborator
• UBS Optimus Foundation: collaborator

Study Sites (5)

The Children's Infectious Disease Clinical Research Unit; University of Stellenbosch

Cape Town, Western Cape, 7505, South Africa

Location

Enhancing Care Foundation; Wendworth Hospital

Durban, 4013, South Africa

Location

Perinatal HIV Research Unit

Johannesburg, 1864, South Africa

Location

Shandukani Research WRHI

Johannesburg, 2001, South Africa

Location

Empilweni Services and Research Unit

Johannesburg, 2093, South Africa

Location

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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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  PMID: 37988391 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.

  PMID: 32071055 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.

  PMID: 30529029 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Tuberculosis

Interventions

Lopinavir; Ritonavir

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles

Study Officials

• Mark Cotton, Professor

  University of Stellenbosch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2014
• First Posted: January 28, 2015
• Study Start: January 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 11, 2017

Record last verified: 2017-05

Locations

ZA (5)