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

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00623597
First received: February 18, 2008
Last updated: September 23, 2010
Last verified: September 2010
History of Changes
  Purpose

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: saquinavir [Invirase]
Drug: ritonavir
 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:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

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: June 2010
Arms Assigned Interventions
Experimental: 1 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

  Eligibility

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

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

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

No publications provided

Responsible Party: Disclosures Group, 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 23, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Saquinavir
 Ritonavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013