Trial Information

Summary: 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 Design / Study Details:

• Purpose: Treatment
• Allocation: Non-Randomized
• Masking: Open Label
• Control: Uncontrolled
• Assignment: Single Group
• Endpoints: Pharmacokinetics

Study Type:

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:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 4 Years Max: 6 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: June, 2008

Trial Registration Date: 02/15/2008

Date Last Updated: 09/19/2008

Link To Trial Results

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Trial listings updated: October 6, 2008 at 2:58:51 PM