A PK and Salvage Study for Children With HIV-infection

Phase 4

Completed

• Conditions: HIV Infections
• Interventions: Drug: Lopinavir/r plus saquinavir

• Registration Number: NCT00476359
• Lead Sponsor: The HIV Netherlands Australia Thailand Research Collaboration

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 Timeline

• Study Start: 2003-10
• Study First Submitted: 2007-05-20
• Study First Submitted QC: 2007-05-21
• Study First Posted: 2007-05-22
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-26
• Last Update Posted: 2015-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
double-boosted PI	Lopinavir/r plus saquinavir	double-boosted protease inhibitor combination

Primary Outcome Measures

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

Trial Locations

Locations (3)

Chulalongkorn University Hospital, Department of Pediatrics; 🇹🇭 Bangkok, Thailand

The HIV Netherlands Australia Thailand Research Collaboration; 🇹🇭 Bangkok, Thailand

Khon Kaen University; 🇹🇭 Khon Kaen, Thailand