NCT01307124

Brief Summary

To compare the safety and efficacy of low-dose versus standard dose lopinavir/ritonavir containing HAART regimen in virological suppress, HIV RNA viral load \< 50 copies/ml at 48 week

Trial Health

87
On Track

Trial Health Score

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

Enrollment
199

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

10 active sites

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

First Submitted

Initial submission to the registry

February 3, 2011

Completed
26 days until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

March 25, 2015

Status Verified

March 1, 2015

Enrollment Period

2.1 years

First QC Date

February 3, 2011

Last Update Submit

March 23, 2015

Conditions

HIV-infected Children

Keywords

safety and efficacylow dose LPV/rstandard dose LPV/rHIV infected children

Outcome Measures

Primary Outcomes (1)

  • To compare the safety and efficacy of low-dose versus standard dose lopinavir/ritonavir containing HAART regimen in virological suppress, HIV RNA viral load < 50 copies/ml at 48 week

    proportion of patient who had HIV RNA \< 50 copies/ml Safety issue: patient who had HIV RNA \> 50 copies/ml during the study period will be checked for LPV blood level, if the LPV Cmin \< 1 ug/ml. The dose of LPV/r will be adjusted to appropriate dose.

    48 week

Study Arms (2)

standard dose

ACTIVE COMPARATOR

Arm 1:LPV/r Standard dose BW 25-35 kg 300/75 mg BW \>35-50 kg 400/100 mg

Drug: kaletra

low dose

EXPERIMENTAL

Arm 2:Low dose BW 25-35 kg 200/50 mg BW \>35-50 kg 300/75 mg

Drug: kaletra

Interventions

kaletraDRUG

The study participants will receive Lopinavir/ritonavir heat-stable tablet (100/25 mg or 200/50 mg) q 12 hour plus NRTIs. The other NRTIs is depend on physician discretion. Arm 1:LPV/r Standard dose Arm 2:Low dose BW 25-35 kg 300/75 mg 200/50 mg BW \>35-50 kg 400/100 mg 300/75 mg

low dosestandard dose

Eligibility Criteria

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

You may qualify if:

  • HIV infection children age \< 18 years old
  • Currently on PI regimens
  • HIV RNA viral load \< 50 copies/ml at screening
  • BW 25-50 kg
  • Written informed consent

You may not qualify if:

  • Relevant history or current condition of PI resistance, plasma HIV RNA \> 1000 copies/ml after received the PI regimens for at least 6 months
  • On rifampin, nevirapine, efavirenz which have drug interaction with lopinavir
  • On double boosted protease inhibitors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Srinagarind Hospital, Khon Kaen University

Khon Kaen, Changwat Khon Kaen, Thailand

Location

Bamrasnaradura Institute

Nonthaburi, Changwat Nonthaburi, 11000, Thailand

Location

Queen Sirikit National Institute of Child Health

Bangkok, Thailand

Location

Prapokklao Hospital

Chanthaburi, Thailand

Location

Nakornping Hospital

Chiang Mai, Thailand

Location

Phrachomklao Hospital

Phetchaburi, Thailand

Location

Buddhachinaraj Hospital

Phitsanulok, Thailand

Location

Surin Hospital

Surin, Thailand

Location

Sappasitthiprasong Hospital

Ubonratchathani, Thailand

Location

Udonthani Hospital

Udon Thani, Thailand

Location

Related Publications (2)

  • A randomized study comparing low dose versus standard dose lopinavir/ritonavir among HIV-infected children with virological suppression . Presented at 7th IAS 2013 in June 30-July 3, 2013 in Kuala Lumpur, Malaysia as abstract presentation.

    RESULT

  • Association of SCLO1B1 polymorphism and plasma concentration of lopinavir in HIV-infected children. Presented at 7th IAS 2013 in June 30-July 3, 2013 in Kuala Lumpur, Malaysia as abstract presentation and 5th International Workshop on HIV Pediatrics in June 28-29, 2013 in Kuala Lumpur, Malaysia

    RESULT

Related Links

MeSH Terms

Interventions

lopinavir-ritonavir drug combination

Study Officials

  • Thanyawee Puthanakit, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2011

First Posted

March 2, 2011

Study Start

March 1, 2011

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

March 25, 2015

Record last verified: 2015-03

Locations

TH(10)