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A Phase I/II Study of Invirase® Boosted With Ritonavir in HIV Infected Infants and Children 4 Months to Less Than 6 Years Old
This single arm study will assess the pharmacokinetics, safety and activity of saquinavir (Invirase hard gel capsules, film coated tablets or opened capsules) boosted by combination with ritonavir, in HIV-1 infected infants and children between the ages of 4 months and 6 years. Patients will commence treatment with saquinavir 50mg/kg bid plus ritonavir 2.5mg/kg or 3.0mg/kg (dependent on body weight), and a background antiretroviral regimen. If drug exposures are found to be dissimilar to those previously seen in older children and adults, or are associated with toxicities, subsequent dose adjustments will be made. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.
Details
| Lead sponsor | Hoffmann-La Roche |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 18 |
| Start date | 2008-06 |
| Completion | 2010-03 |
Conditions
- HIV Infections
Interventions
- ritonavir
- saquinavir [Invirase]
Primary outcomes
- Plasma Trough Concentrations (Ctrough) for Saquinavir — Pre-dose at Weeks 8, 12, 24.
Plasma trough concentration is the average steady state concentration prior to morning and evening dose. Ctrough of Saquinavir was normalized to a dose of 50 mg/kg. - Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to Twelve Hours (AUC0-12h) for Saquinavir — Pre-dose and 3, 4, 8, 12 hours (post-dose) on Day 14 (± 2 days), or Day 28(+ 2 days) for patients switching from an Non-nucleoside reverse transcriptase inhibitor [NNRTI] containing regimen).
The area under the plasma concentration-time curve from time zero to twelve hours (AUC0-12h) is area under the plasma concentration-time curve from time zero through actual tlast. The area under the plasma concentration-time curve from time zero to twelve hours of saquinavir was normalized to a dose of 50 mg/kg. - Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) — From Baseline (Day 1) till Week 48 and Follow-up (Week 52)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes - Change In Hematocrit From Baseline — Baseline (Day 1), Week 24 and Week 48
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. - Change In Hemoglobin, Total Protein And Total Albumin From Baseline — Baseline (Day 1), Week 24 and Week 48
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. - Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline — Baseline (Day 1), Week 24 and Week 48
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Countries
Argentina, Spain, Thailand