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: October 6, 2014
Last verified: October 2014
  Purpose

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.


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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Argentina
Buenos Aires, Argentina, 1425
Buenos Aires, Argentina, 1202
Santa Fe, Argentina, 3000
Spain
Madrid, Spain, 28046
Madrid, Spain, 28905
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: 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: October 6, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Ritonavir
Saquinavir
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 October 22, 2014