Trial information
A Study of Invirase (Saquinavir)/Ritonavir in HIV-Infected Infants and Children.
Status: Recruiting
Protocol number: NV20911
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open label study of the pharmacokinetics, safety and antiviral activity of Invirase boosted with ritonavir in HIV-infected infants and children 4 months to <6 years old.
Brief summary: 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. Target sample size is 24.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Pharmacokinetics study
Condition: HIV Infections
Intervention type: Drug
Intervention name: saquinavir [Invirase]
Primary outcome: 1. AUC0-12h and Ctrough for saquinavir Time frame: Day 14 (or Day 28 for patients switching from an NNRTI-containing regimen)
2. AEs and laboratory parameters Time frame: Week 24 and Week 48
Key secondary outcomes: 1. AUC0-12h and Ctrough for ritonavir Time frame: Day 14 (or Day 28 for patients switching from an NNRTI-containing regimen)
2. Change from baseline in HIV-RNA, CD4 and CD8. Time frame: Week 24 and Week 48
Inclusion criteria:
- infants and children, 4 months to <6 years;
- confirmed HIV-1 infection;
- patients for whom saquinavir/ritonavir together with >=2 background ARVs is considered appropriate.
Exclusion criteria:
- body weight >4kg/8.8 pounds;
- use of any concomitant medications that may interfere with the pharmacokinetics of saquinavir or ritonavir;
- malabsorption, severe chronic diarrhea or vomiting within 28 days of the study.
Gender: Males or Females
Age limits: Min: 4 Months Max: 6 Years
Accepts healthy volunteers: No
Anticipated start date: June, 2008
Trial registration date: 02/15/2008
Date last updated: 8/19/2008
Link to trial result
This trial is being conducted at the following locations:
Argentina
Brazil
- Belo Horizonte
- Nova Iguaçu
- Porto Alegre
- Ribeirão Preto
- Salvador
- Sao Paulo
Spain
Thailand
- Bangkok
- Khon Kaen
- Pathumwan
- Payathai
