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A PK and Salvage Study for Children With HIV-infection

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Lopinavir/r plus saquinavir
Sponsored by
The HIV Netherlands Australia Thailand Research Collaboration
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Lopinavir/r, Saquinavir, Dual boosted PIs, Pharmacokinetics, HIV children, C min, Second line HAART, ARV, VL failure, Dosage, To evaluate treatment response, Treatment Experienced

Eligibility Criteria

1 Year - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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
  2. Subject is less than or equal to 16 years of age at the day of the first dosing.
  3. Subject is failing a current NRTI and/or NNRTI containing regimen and is naïve to protease inhibitor containing therapy.
  4. Results of biochemistry and haematology testing should be within pre-specified ranges.
  5. Subject is able to swallow capsules
  6. Caretaker(s) is/are able and willing to sign the Informed Consent Form prior to screening evaluations.

Exclusion Criteria:

  1. History of sensitivity/idiosyncrasy to lopinavir, ritonavir, saquinavir or chemically related compounds or excipients which may be employed in the trial.
  2. Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
  3. Inability of both child and caregiver(s) to understand the nature and extent of the trial and the procedures required.

  4. 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
  5. Pregnancy

Sites / Locations

  • Chulalongkorn University Hospital, Department of Pediatrics
  • The HIV Netherlands Australia Thailand Research Collaboration
  • Khon Kaen University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

double-boosted PI

Arm Description

double-boosted protease inhibitor combination

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 20, 2007
Last Updated
March 26, 2015
Sponsor
The HIV Netherlands Australia Thailand Research Collaboration
Collaborators
Roche for trial and Saquinavir,and Abbott for Kaletra
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1. Study Identification

Unique Protocol Identification Number
NCT00476359
Brief Title
A PK and Salvage Study for Children With HIV-infection
Official Title
Lopinavir/r Plus Saquinavir Salvage Therapy in HIV-infected Children With NRTI and/or NNRTI Failure: PK and Two-year Treatment Follow up
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The HIV Netherlands Australia Thailand Research Collaboration
Collaborators
Roche for trial and Saquinavir,and Abbott for Kaletra

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Lopinavir/r, Saquinavir, Dual boosted PIs, Pharmacokinetics, HIV children, C min, Second line HAART, ARV, VL failure, Dosage, To evaluate treatment response, Treatment Experienced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
double-boosted PI
Arm Type
Other
Arm Description
double-boosted protease inhibitor combination
Intervention Type
Drug
Intervention Name(s)
Lopinavir/r plus saquinavir
Intervention Description
lopinavir/ritonavir 230/57.5 mg/m2 orally twice daily and saquinavir 50 mg/kg orally twice daily
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kiat Ruxrungtham, MD
Organizational Affiliation
HIV-NAT, Bangkok, Thailand
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pope Kosalaraksa, MD
Organizational Affiliation
Khon Kaen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chulalongkorn University Hospital, Department of Pediatrics
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
The HIV Netherlands Australia Thailand Research Collaboration
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Khon Kaen University
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
16220084
Citation
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.
Results Reference
result
Citation
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
Results Reference
result
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
PubMed Identifier
19430099
Citation
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.
Results Reference
result
PubMed Identifier
18520443
Citation
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.
Results Reference
result
Links:
URL
http://www.hivnat.org
Description
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

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A PK and Salvage Study for Children With HIV-infection

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