Lopinavir/Ritonavir (LPV/r) Tablet in HIV Infected Children | NCT01139905

Studies
Lopinavir/Ritonavir (LPV/r) Tablet in HIV Infected Children

NCT01139905

Sponsor

The HIV Netherlands Australia Thailand Research Collaboration

Status

Completed

Last Update Posted

Mar 26, 2015Estimated

Enrollment

24Actual

Phase

Phase 2

Conditions

HIV-1 Infections

Interventions

lopinavir/ritonavir

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Mar 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

Jun 4, 2010

First Submission Date that Met QC Criteria

Jun 8, 2010

First Posted Date

Jun 9, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2015

Last Update Posted Date

Mar 26, 2015Estimated

Name	Class
Chulalongkorn University	OTHER
Radboud University Medical Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To study the pharmacokinetics of low-dose lopinavir/ritonavir tablet in HIV-1 infected Thai children.

Detailed Description

This is an open-label, single arm study to compare standard dose with a new tablet formulation of a lower dose of lopinavir/ritonavir in HIV-1 infected children.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Other	standard dose of lopinavir/ritonavir 100/25 mg tablet q 12 hour	Other: lopinavir/ritonavir

Interventions

Name	Type	Description	Arm Group Labels	Other Names
lopinavir/ritonavir	Other	standard dose of lopinavir/ritonavir 100/25 mg tablet q 12 hour.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

HIV infection
Age < 18 years old
BW > 25 kg
HIV RNA viral load < 50 copies within 6 months
Written informed consent

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kiat Ruxrungtham, MD	The HIV Netherlands Australia Thailand Research Collaboration	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
HIV-NAT		Bangkok		10330	Thailand

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22293065	Result	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.

ID	Term
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds