NCT00887120

Brief Summary

To study the pharmacokinetics of low-dose and standard dose, lopinavir/ritonavir in ARV PI naive HIV-1 infected Thai children. To study clinical and immunological efficacy after 48 weeks of lopinavir/ritonavir in PI naïve HIV-1 infected Thai children

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2 hiv-infections

Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 23, 2009

Completed
Last Updated

July 17, 2020

Status Verified

July 1, 2020

Enrollment Period

1.8 years

First QC Date

April 21, 2009

Last Update Submit

July 15, 2020

Conditions

HIV Infections

Keywords

Second line treatmenttherapeutic drug monitoringAsiaLPVchildrenpharmacokineticTo study the pharmacokinetics of low-dose and standard dose, lopinavir/ritonavir in Protease inhibitor (PI)- naive HIV-1 infected Thai patients.To study clinical and immunological efficacy after 48-weeks of lopinavir/ritonavir-based antiretroviral therapy in PI naive HIV-1 infected Thai patients.

Outcome Measures

Primary Outcomes (1)

  • pharmacokinetics of standard vs low dose LPV/r

    4 weeks after start ART

Secondary Outcomes (1)

  • efficacy and safety of standard and low dose LPV/r

    48 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Lopinavir/ritonavir standard dose + zidovudine and lamivudine

Drug: Lopinavir/ritonavir standard dose According to WHO simplified dosing table

2

ACTIVE COMPARATOR

Lopinavir/ritonavir low dose (70% of standard dose) + zidovudine and lamivudine

Drug: Lopinavir/ritonavir low dose ( 70% of WHO recommended dosing table)

Interventions

Lopinavir/ritonavir standard dose According to WHO simplified dosing tableDRUG

* BW 6-7.9 kg: 1.5 mL oral q 12 hr * BW 8.0-16.9 kg: 2.0 ml oral q 12 hr * BW 17.0-19.9 kg: 2.5 ml oral q 12 hr * BW 20.0 - 24.9 kg: 3.0 ml oral q 12 hr * BW 25.0 - 29.9 kg: 3.5 ml oral q 12 hr * BW 30.0-34.9 kg: 4.0 ml oral q 12 hr * BW \> 35 kg: 5.0 ml oral q 12 hr Dose of Zidovudine (AZT) is 180-240 mg/m2 per dose every 12 hours Dose of Lamivudine (3TC) is 4 mg/kg every 12 hours Dose of Lopinavir/ritonavir (LPV/r)

1
Lopinavir/ritonavir low dose ( 70% of WHO recommended dosing table)DRUG

* BW 6-7.9 kg: 1.0 mL oral q 12 hr * BW 8.0-16.9 kg: 1.5 ml oral q 12 hr * BW 17.0-19.9 kg: 1.8 ml oral q 12 hr * BW 20.0 - 24.9 kg: 2.0 ml oral q 12 hr * BW 25.0 - 29.9 kg: 2.5 ml oral q 12 hr * BW 30.0-34.9 kg: 3.0 ml oral q 12 hr * BW \> 35 kg: 3.5 ml oral q 12 h Dose of Zidovudine (AZT) is 180-240 mg/m2 per dose every 12 hours Dose of Lamivudine (3TC) is 4 mg/kg every 12 hours Dose of Lopinavir/ritonavir (LPV/r)

2

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age from 2- 18 years old
  • Documented positive test for HIV-1 infection
  • PI-naïve
  • HIV RNA viral load \> 1,000 copies
  • Written informed consent

You may not qualify if:

  • Active opportunistic infection
  • Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion.
  • Use of concomitant medication that may interfere with the pharmacokinetics of lopinavir/ritonavir
  • Pregnancy or lactating
  • Inability to understand the nature and extent of the study and the procedures required.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HIV-NAT, Thai Red Cross AIDS Research Center, Bangkok

Bangkok, 10330, Thailand

Location

Related Publications (1)

  • Puthanakit T, van der Lugt J, Bunupuradah T, Ananworanich J, Gorowara M, Phasomsap C, Jupimai T, Boonrak P, Pancharoen C, Burger D, Ruxrungtham K. Pharmacokinetics and 48 week efficacy of low-dose lopinavir/ritonavir in HIV-infected children. J Antimicrob Chemother. 2009 Nov;64(5):1080-6. doi: 10.1093/jac/dkp322. Epub 2009 Sep 2.

    PMID: 19729375DERIVED

Related Links

MeSH Terms

Conditions

HIV Infections

Interventions

LopinavirRitonavir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsThiazolesSulfur CompoundsOrganic ChemicalsAzoles

Study Officials

  • Kiat Ruxrungtham, MD

    Department of Medicine, Faculty of Medicine, Chulalongkorn University and Thai Red Cross Aids Research Centre - HIV-NAT

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2009

First Posted

April 23, 2009

Study Start

April 1, 2007

Primary Completion

January 1, 2009

Study Completion

February 1, 2009

Last Updated

July 17, 2020

Record last verified: 2020-07

Locations

TH(1)