NCT00476359

Brief Summary

To evaluate the pharmacokinetics (PK) of LPV/r with saquinavir in HIV-1 infected children. To evaluate treatment response (clinical, immunological and virological) to LPV/r, SQV in Thai children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4 hiv-infections

Timeline
Completed

Started Oct 2003

Longer than P75 for phase_4 hiv-infections

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

October 1, 2003

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

March 27, 2015

Status Verified

March 1, 2015

Enrollment Period

5.1 years

First QC Date

May 20, 2007

Last Update Submit

March 26, 2015

Conditions

HIV Infections

Keywords

Lopinavir/rSaquinavirDual boosted PIsPharmacokineticsHIV childrenC minSecond line HAARTARVVL failureDosageTo evaluate treatment responseTreatment Experienced

Outcome Measures

Primary Outcomes (1)

  • Intensive 0-12h PK sampling for plasma levels of LPV and SQV, and blood sampling. CD4 viral load safety lab every 3 months.

    96 week

Study Arms (1)

double-boosted PI

OTHER

double-boosted protease inhibitor combination

Drug: Lopinavir/r plus saquinavir

Interventions

Lopinavir/r plus saquinavirDRUG

lopinavir/ritonavir 230/57.5 mg/m2 orally twice daily and saquinavir 50 mg/kg orally twice daily

double-boosted PI

Eligibility Criteria

Age1 Year - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Confirmed HIV-1 infection by HIV-DNA PCR if \< 18 months old or by HIV ELISA if greater than or equal to 18 months old
  • Subject is less than or equal to 16 years of age at the day of the first dosing.
  • Subject is failing a current NRTI and/or NNRTI containing regimen and is naïve to protease inhibitor containing therapy.
  • Results of biochemistry and haematology testing should be within pre-specified ranges.
  • Subject is able to swallow capsules
  • Caretaker(s) is/are able and willing to sign the Informed Consent Form prior to screening evaluations.

You may not qualify if:

  • History of sensitivity/idiosyncrasy to lopinavir, ritonavir, saquinavir or chemically related compounds or excipients which may be employed in the trial.
  • Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
  • Inability of both child and caregiver(s) to understand the nature and extent of the trial and the procedures required.
  • Use of any of concomitant medication, including the drug listed below, that may interfere with the pharmacokinetics of LPV/r or SQV.
  • NNRTIs
  • Rifampicin
  • Rifabutin
  • Phenobarbital
  • Phenytoine
  • Carbamazepine
  • Dexamethasone
  • Ketoconazole
  • Clarithromycin
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Chulalongkorn University Hospital, Department of Pediatrics

Bangkok, Bangkok, 10330, Thailand

Location

The HIV Netherlands Australia Thailand Research Collaboration

Bangkok, Bangkok, 10330, Thailand

Location

Khon Kaen University

Khon Kaen, Changwat Khon Kaen, 40002, Thailand

Location

Related Publications (6)

  • Ananworanich J, Kosalaraksa P, Hill A, Siangphoe U, Bergshoeff A, Pancharoen C, Engchanil C, Ruxrungtham K, Burger D; HIV-NAT 017 Study Team. Pharmacokinetics and 24-week efficacy/safety of dual boosted saquinavir/lopinavir/ritonavir in nucleoside-pretreated children. Pediatr Infect Dis J. 2005 Oct;24(10):874-9. doi: 10.1097/01.inf.0000180578.38584.da.

    PMID: 16220084RESULT

  • Kosalaraksa P, Engchanil C, Bunupuradah T, Luesomboon W, Sunthornkachit R, Bunruen S, Intasan J, Jupimai T, Hirunwadee N, Lumbiganon P, Ruxrungtham K on behalf of the PREDICT study team. Prevalence of anemia and impact of iron status in Thai and Cambodian HIV infected children with moderate immunosuppression (PREDICT study), poster No. TUPEB 137. Poster presented at the 4th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention, Sydney, Australia, July 22-25, 2007

    RESULT

  • Jasper van der Lugt, Torsak Bunupuradah, Pope Kosalaraksa, Thanyawee Puthanakit, Chulapan Engchanil, Waraporn Sakornjun, Meena Gorowara, ROCHE, Kiat Ruxrungtham, David Burger, Jintanat Ananworanich: Therapeutic Drug Monitoring of lopinavir and saquinavir in Thai HIV infected Children. Poster will be presented at the 15th Conference on Retroviruses and Opportunistic Infections, Boston, USA, February 3-7, 2008.

    RESULT

  • Torsak Bunupuradah, Pope Kosalaraksa, Chulapan Engchanil, Pitch Boonrak, Tawan Hirunyanulux, Sasiwimol Ubolyam, Pagakrong Lumbiganon, Kiat Ruxrungtham, Emily Labriola-Tompkins, Jintanat Ananworanich, and HIV-NAT 017 Study Team: Efficacy and safety of double boosted SQV/LPV/r combination at 96 weeks in Thai children who have failed NRTI/NNRTI-.based regimens. Abstract # R-143. Abstract will be presented at the 15th Conference on Retroviruses and Opportunistic Infections, Boston, USA, February 3-7, 2008.

    RESULT

  • Bunupuradah T, van der Lugt J, Kosalaraksa P, Engchanil C, Boonrak P, Puthanakit T, Mengthaisong T, Mahanontharit A, Lumbiganon P, Tompkins E, Burger D, Ruxrungtham K, Ananworanich J; HIV-NAT 017 Study Team. Safety and efficacy of a double-boosted protease inhibitor combination, saquinavir and lopinavir/ritonavir, in pretreated children at 96 weeks. Antivir Ther. 2009;14(2):241-8.

    PMID: 19430099RESULT

  • Kosalaraksa P, Bunupuradah T, Engchanil C, Boonrak P, Intasan J, Lumbiganon P, Burger D, Ruxrungtham K, Schutz M, Ananworanich J; HIV-NAT 017 Study Team. Double boosted protease inhibitors, saquinavir, and lopinavir/ritonavir, in nucleoside pretreated children at 48 weeks. Pediatr Infect Dis J. 2008 Jul;27(7):623-8. doi: 10.1097/INF.0b013e31816b4539.

    PMID: 18520443RESULT

Related Links

MeSH Terms

Conditions

HIV Infections

Interventions

Saquinavir

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)

IsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinolines

Study Officials

  • Kiat Ruxrungtham, MD

    HIV-NAT, Bangkok, Thailand

    PRINCIPAL INVESTIGATOR

  • Pope Kosalaraksa, MD

    Khon Kaen University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 20, 2007

First Posted

May 22, 2007

Study Start

October 1, 2003

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

March 27, 2015

Record last verified: 2015-03

Locations

TH(3)