A PK and Salvage Study for Children With HIV-infection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2008-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HIV Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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double-boosted PI

double-boosted protease inhibitor combination

Group Type OTHER

Lopinavir/r plus saquinavir

Intervention Type DRUG

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

Interventions

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Lopinavir/r plus saquinavir

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No