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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
First received: February 18, 2008
Last updated: September 1, 2015
Last verified: September 2015
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.

Condition Intervention Phase
HIV Infections
Drug: ritonavir
Drug: saquinavir [Invirase]
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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.

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 18
Study Start Date: June 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: ritonavir
2.5-3.0mg/kg po bid (starting dose) for 48 weeks
Drug: saquinavir [Invirase]
50mg/kg po bid (starting dose) for 48 weeks


Ages Eligible for Study:   4 Months to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00623597

Buenos Aires, Argentina, 1202
Buenos Aires, Argentina, 1425
Santa Fe, Argentina, 3000
Madrid, Spain, 28046
Madrid, Spain, 28905
Valencia, Spain, 46009
Bangkok, Thailand, 10400
Khon Kaen, Thailand, 40002
Pathumwan, Thailand, 10330
Payathai, Thailand, 10400
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00623597     History of Changes
Other Study ID Numbers: NV20911, 2007-004617-34
Study First Received: February 18, 2008
Last Updated: September 1, 2015
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 30, 2015