A Study of Invirase (Saquinavir)/Ritonavir in HIV-Infected Infants and Children.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00623597
First received: February 18, 2008
Last updated: July 7, 2014
Last verified: July 2014

February 18, 2008
July 7, 2014
June 2008
March 2010   (final data collection date for primary outcome measure)
  • AUC0-12h and Ctrough for saquinavir [ Time Frame: Day 14 (or Day 28 for patients switching from an NNRTI-containing regimen) ] [ Designated as safety issue: No ]
  • AEs and laboratory parameters [ Time Frame: Week 24 and Week 48 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00623597 on ClinicalTrials.gov Archive Site
  • AUC0-12h and Ctrough for ritonavir [ Time Frame: Day 14 (or Day 28 for patients switching from an NNRTI-containing regimen) ] [ Designated as safety issue: No ]
  • Change from baseline in HIV-RNA, CD4 and CD8. [ Time Frame: Week 24 and Week 48 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Invirase (Saquinavir)/Ritonavir in HIV-Infected Infants and Children.
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.

This single arm study will assess the pharmacokinetics, safety and activity of s aquinavir (Invirase hard gel capsules, film coated tablets or opened capsules) b oosted by combination with ritonavir, in HIV-1 infected infants and children bet ween the ages of 4 months and 6 years. Patients will commence treatment with saq uinavir 50mg/kg bid plus ritonavir 2.5mg/kg or 3.0mg/kg (dependent on body weigh t), and a background antiretroviral regimen. If drug exposures are found to be d issimilar to those previously seen in older children and adults, or are associat ed with toxicities, subsequent dose adjustments will be made. The anticipated ti me on study treatment is 3-12 months, and the target sample size is <100 individ uals.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: saquinavir [Invirase]
    50mg/kg po bid (starting dose) for 48 weeks
  • Drug: ritonavir
    2.5-3.0mg/kg po bid (starting dose) for 48 weeks
Experimental: 1
Interventions:
  • Drug: saquinavir [Invirase]
  • Drug: ritonavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
March 2010
March 2010   (final data collection date for primary outcome measure)

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.
Both
4 Months to 6 Years
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Spain,   Thailand
 
NCT00623597
NV20911, 2007-004617-34
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP