NCT00626301

Brief Summary

The purpose of this study is to evaluate the efficacy (clinical, immunological, virological outcome), pharmacokinetics and safety of lopinavir/ritonavir (LPV/r) monotherapy maintenance in Thai children after viral load suppression with double boosted protease inhibitors (PIs).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4 hiv-infections

Timeline
Completed

Started Nov 2007

Geographic Reach
1 country

3 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

Study Start

First participant enrolled

November 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 29, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

March 26, 2015

Status Verified

March 1, 2015

Enrollment Period

1.8 years

First QC Date

February 21, 2008

Last Update Submit

March 25, 2015

Conditions

HIV Infections

Keywords

efficacysafetypharmacokineticsLPV/r monotherapyThai childrenefficacy safety LPV/r monotherapy maintenancetreatment experienced

Outcome Measures

Primary Outcomes (1)

  • To evaluate efficacy (clinical, immunological, virological outcome), pharmacokinetics and safety of LPV/r monotherapy maintenance in Thai children after viral load suppression with double boosted PIs

    48 weeks

Study Arms (1)

1

EXPERIMENTAL

Children who have completed HIV-NAT 017. Children treated with other double boosted PIs such as indinavir plus lopinavir/ ritonavir are also included.

Drug: LPV/r

Interventions

LPV/rDRUG

LPV/r 230/57.5 mg/m2 orally q12h or the adjusted dose based on therapeutic drug monitoring of LPV/r prior to enrollment as maintenance monotherapy

1

Eligibility Criteria

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

You may qualify if:

  • HIV infected children ages 2 to 18 years
  • Treated with double boosted PIs during the last three months
  • Two consecutive plasma HIV-RNA levels \< 50 copies/ml at least 3 months apart
  • Willing to restart HAART with the same regimen as before enrollment, when indicated
  • Signed written informed consent

You may not qualify if:

  • Active AIDS-defining disease at screening
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of Pediatrics, Chulalongkorn University Hospital

Bangkok, Bangkok, 10330, Thailand

Location

HIV-NAT

Bangkok, Bangkok, 10330, Thailand

Location

Department of Pediatrics, Khon Kaen University

Khon Kaen, Changwat Khon Kaen, Thailand

Location

Related Publications (3)

  • Bunupuradah T, Panthong A, Kosalaraksa P, Wongsabut J, Puthanakit T, Lumbiganon P, Chuanjaroen T, Sopharak C, Udompanit T, Prasitsuebsai W, Pancharoen C, Ananworanich J; HIV-NAT 077 Study Team. Simplifying antiretroviral therapy to lopinavir/ritonavir monotherapy did not improve quality of life and therapy adherence in pretreated HIV-infected children. AIDS Res Hum Retroviruses. 2014 Mar;30(3):260-5. doi: 10.1089/AID.2013.0204. Epub 2013 Dec 21.

    PMID: 24274723RESULT

  • Kosalaraksa P, Ananworanich J, Puthanakit T, Pinyakorn S, Lumbiganon P, Chuanjaroen T, Chobkarjing U, Phanuphak P, Pancharoen C, Bunupuradah T; HIV-NAT 077 Study Team. Long-term lopinavir/ritonavir monotherapy in HIV-infected children. Pediatr Infect Dis J. 2013 Apr;32(4):350-3. doi: 10.1097/INF.0b013e31827b1bd3.

    PMID: 23190774RESULT

  • Bunupuradah T, Kosalaraksa P, Puthanakit T, Mengthaisong T, Wongsabut J, Lumbiganon P, Phanuphak P, Burger D, Pancharoen C, Ananworanich J; HIV-NAT 077 Study Team. Monoboosted lopinavir/ritonavir as simplified second-line maintenance therapy in virologically suppressed children. AIDS. 2011 Jan 28;25(3):315-23. doi: 10.1097/QAD.0b013e32834231f5.

    PMID: 21157298RESULT

Related Links

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

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

Study Officials

  • Praphan Phanuphak, MD, PhD

    HIV-NAT, Thai Red Cross - AIDS Research Centre

    PRINCIPAL INVESTIGATOR

  • Pope Kosalaraksa, MD

    Department of Pediatrics, Khon Kaen University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 21, 2008

First Posted

February 29, 2008

Study Start

November 1, 2007

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

March 26, 2015

Record last verified: 2015-03

Locations

TH(3)