A PK and Salvage Study for Children With HIV-infection

Study Overview
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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.

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.

Official Title
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Lopinavir/r Plus Saquinavir Salvage Therapy in HIV-infected Children With NRTI and/or NNRTI Failure: PK and Two-year Treatment Follow up

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Lopinavir/r plus saquinavir


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: double-boosted PI<br>double-boosted protease inhibitor combination | Drug: Lopinavir/r plus saquinavir<br>* lopinavir/ritonavir 230/57.5 mg/m2 orally twice daily and saquinavir 50 mg/kg orally twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lopinavir/r, Saquinavir, Dual boosted PIs, Pharmacokinetics, HIV children, C min, Second line HAART, ARV, VL failure, Dosage, To evaluate treatment response, Treatment Experienced