Trial | NCT00476359  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    50
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.
Study Started
Oct 31
2003
Primary Completion
Nov 30
2008
Study Completion
Nov 30
2008
Last Update
Mar 27
2015
Estimate

Drug Lopinavir/r plus saquinavir

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

double-boosted PI Other

double-boosted protease inhibitor combination

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
No Results Posted