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Clinical Trials

MainTitle

A PK and Salvage Study for Children With HIV-infection

This study has been completed
Sponsor
The HIV Netherlands Australia Thailand Research Collaboration

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
Purpose

Purpose

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.

Condition Intervention Phase
HIV Infections

Drug : Lopinavir/r plus saquinavir
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Further study details as provided by The HIV Netherlands Australia Thailand Research Collaboration:

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. [ Time Frame: 96 week ]

Enrollment: 50
Study Start Date: October 2003
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Other: double-boosted PI
double-boosted protease inhibitor combination
Drug: Lopinavir/r plus saquinavir

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

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.

Eligibility

Eligibility

Ages Eligible for Study: 1 Year to 16 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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:
  • 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

      contacts and locations

      Contacts and Locations

      Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

      Please refer to this study by its ClinicalTrials.gov identifier: NCT00476359

      Locations

      Thailand
      Chulalongkorn University Hospital, Department of Pediatrics
      Bangkok, Thailand, 10330
      The HIV Netherlands Australia Thailand Research Collaboration
      Bangkok, Thailand, 10330
      Khon Kaen University
      Khon Kaen, Thailand, 40002

      Sponsors and Collaborators

      The HIV Netherlands Australia Thailand Research Collaboration
      Roche for trial and Saquinavir,and Abbott for Kaletra

      Investigators

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

      More Information

      Additional Information:

      The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

      Responsible Party: The HIV Netherlands Australia Thailand Research Collaboration  
      ClinicalTrials.gov Identifier: NCT00476359   History of Changes  
      Other Study ID Numbers: HIV-NAT 017  
      Study First Received: May 20, 2007  
      Last Updated: March 26, 2015  

      Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:

      Lopinavir/r
      Saquinavir
      Dual boosted PIs
      Pharmacokinetics
      HIV children
      C min
      Second line HAART
      ARV
      VL failure
      Dosage
      To evaluate treatment response
      Treatment Experienced

      Additional relevant MeSH terms:
      Infection
      HIV Infections
      Acquired Immunodeficiency Syndrome
      Lopinavir
      Saquinavir

      ClinicalTrials.gov processed this data on October 17, 2017
      This information is provided by ClinicalTrials.gov.