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:
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
NCT00476359
First received: May 20, 2007
Last updated: June 4, 2010
Last verified: June 2010

May 20, 2007
June 4, 2010
October 2003
November 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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 ]
Complete list of historical versions of study NCT00476359 on ClinicalTrials.gov Archive Site
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A PK and Salvage Study for Children With HIV-infection
Lopinavir/r Plus Saquinavir Salvage Therapy in HIV-infected Children With NRTI and/or NNRTI Failure: PK and Two-year Treatment Follow up

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Drug: Lopinavir/r plus saquinavir
lopinavir/ritonavir 230/57.5 mg/m2 orally twice daily and saquinavir 50 mg/kg orally twice daily
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
November 2008
November 2008   (final data collection date for primary outcome measure)

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
Both
1 Year to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00476359
HIV-NAT 017
Yes
The Institutional Review Board of the Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand
The HIV Netherlands Australia Thailand Research Collaboration
Roche for trial and Saquinavir,and Abbott for Kaletra
Principal Investigator: Kiat Ruxrungtham, MD HIV-NAT, Bangkok, Thailand
Principal Investigator: Pope Kosalaraksa, MD Khon Kaen University
The HIV Netherlands Australia Thailand Research Collaboration
June 2010

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