A PK and Salvage Study for Children With HIV-infection

This study has been completed.

Sponsor:

Collaborator:

Roche for trial and Saquinavir,and Abbott for Kaletra

Information provided by (Responsible Party):

The HIV Netherlands Australia Thailand Research Collaboration

ClinicalTrials.gov Identifier:

NCT00476359

First received: May 20, 2007

Last updated: March 26, 2015

Last verified: March 2015

History of Changes

Tracking Information

First Received Date ^ICMJE

May 20, 2007

Last Updated Date

March 26, 2015

Start Date ^ICMJE

October 2003

Primary Completion Date

November 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Intensive 0-12h PK sampling for plasma levels of LPV and SQV, and blood sampling. CD4 viral load safety lab every 3 months. [ Time Frame: 96 week ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00476359 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A PK and Salvage Study for Children With HIV-infection

Official Title ^ICMJE

Lopinavir/r Plus Saquinavir Salvage Therapy in HIV-infected Children With NRTI and/or NNRTI Failure: PK and Two-year Treatment Follow up

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.

Detailed Description

The PK and 24 week data has been published in Pediatric Infectious Diseases Journal. It showed that plasma drug concentrations of saquinavir, lopinavir and ritonavir were at the higher limits of expected ranges for adult treatment at approved dosages (1000/100 mg BID for saquinavir, 400/100 mg BID for lopinavir/r). The regimen was well tolerated and showed significant CD4 rise and VL decline at 48 weeks.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Drug: Lopinavir/r plus saquinavir

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

Study Arms

double-boosted PI

double-boosted protease inhibitor combination

Intervention: Drug: Lopinavir/r plus saquinavir

Publications *

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.
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
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.
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.
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.
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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2008

Primary Completion Date

November 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

1 Year to 16 Years (Child)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Thailand

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00476359

Other Study ID Numbers ^ICMJE

HIV-NAT 017

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

The HIV Netherlands Australia Thailand Research Collaboration

Study Sponsor ^ICMJE

The HIV Netherlands Australia Thailand Research Collaboration

Collaborators ^ICMJE

Roche for trial and Saquinavir,and Abbott for Kaletra

Investigators ^ICMJE

Principal Investigator:	Kiat Ruxrungtham, MD	HIV-NAT, Bangkok, Thailand
Principal Investigator:	Pope Kosalaraksa, MD	Khon Kaen University

PRS Account

The HIV Netherlands Australia Thailand Research Collaboration

Verification Date

March 2015

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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