Once daily DArunavir/ritonavir in HIV-infected children 6-12 years old: a PHarmacokiNEtic validation of model-based dosing recommendations (DAPHNE)

Phase 4

Completed

Conditions: HIV-infection
10047438

Registration Number: NL-OMON44252

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 12

Inclusion Criteria

1. Parents/carers are able and willing to sign the informed consent form prior to screening evaluations
2. Subject is HIV infected
3. Subject is at least 6 and not older than 12 years at day of screening
4. Subject has a body weight of at least 15kg
5. Subject is able to swallow tablets
6. Subject has an undetectable viral load (<50 copies/mL) for the last 6 months prior to screening (at least 2 measurements)
7. ART regimen consists of darunavir/ritonavir and 2 NRTIs

Exclusion Criteria

1. Inability to understand the nature and extent of the trial and the procedures required
2. Documented history of sensitivity/idiosyncrasy to darunavir or ritonavir medicinal products or its excipients
3. Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion
4. Abnormal renal or liver function (grade 3 or above)
5. Participation in a drug trial within 60 days prior to the first dose
6. Hemoglobin < 10 g/dL (6.0 mmol/L)
7. Children who have previously failed virologically on a PI containing regimen
8. Acute illness
9. Receiving concomitant therapy except for prophylaxis for opportunistic infections.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Area under the plasma concentration time profile (AUC) for a dose interval of<br /><br>24 hours</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Ratio of the AUC and other pharmacokinetic parameters after once daily,<br /><br>compared to twice daily dosing.<br /><br>- Safety of darunavir once daily<br /><br>- Acceptability of once daily darunavir compared to previous treatment regime</p><br>