NCT01139905

Brief Summary

To study the pharmacokinetics of low-dose lopinavir/ritonavir tablet in 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

Timeline
Completed

Started Apr 2010

Shorter than P25 for phase_2

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, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 9, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

March 26, 2015

Status Verified

March 1, 2015

Enrollment Period

11 months

First QC Date

June 4, 2010

Last Update Submit

March 24, 2015

Conditions

HIV-1 Infections

Keywords

Lopinavir/ritonavirpharmacokineticlow doseHIV-infected childrenpharmacokinetics of low-dose lopinavir/ritonavir in HIV-1 infected Thai children.

Outcome Measures

Primary Outcomes (1)

  • assess the level of lopinavir trough level >1 mg/L in low dose lopinavir (reduction by 70%)

    study drug Aluvia (lopinavir/ritonavir 100/25 mg)

    4 months

Study Arms (1)

1

OTHER

standard dose of lopinavir/ritonavir 100/25 mg tablet q 12 hour

Other: lopinavir/ritonavir

Interventions

lopinavir/ritonavirOTHER

standard dose of lopinavir/ritonavir 100/25 mg tablet q 12 hour.

1

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • HIV infection
  • Age \< 18 years old
  • BW \> 25 kg
  • HIV RNA viral load \< 50 copies within 6 months
  • 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 medications that may interfere with the pharmacokinetics of lopinavir/ritonavir

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HIV-NAT

Bangkok, 10330, Thailand

Location

Related Publications (1)

  • Klinklom A, Puthanakit T, Gorowara M, Phasomsap C, Kerr S, Sriheara C, Ananworanich J, Burger D, Ruxrungtham K, Pancharoen C. Low dose lopinavir/ritonavir tablet achieves adequate pharmacokinetic parameters in HIV-infected Thai adolescents. Antivir Ther. 2012;17(2):283-9. doi: 10.3851/IMP1958. Epub 2011 Nov 10.

    PMID: 22293065RESULT

Related Links

MeSH Terms

Interventions

Lopinavir

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Kiat Ruxrungtham, MD

    The HIV Netherlands Australia Thailand Research Collaboration

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2010

First Posted

June 9, 2010

Study Start

April 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

March 26, 2015

Record last verified: 2015-03

Locations

TH(1)