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

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00623597

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 II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study
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: AIDS

Drug Information available for: Saquinavir Saquinavir mesylate Ritonavir

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 ]

Estimated Enrollment:	19
Study Start Date:	June 2008
Estimated Study Completion Date:	August 2010

Arms	Assigned Interventions
1: Experimental	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

VALENCIA, Spain, 46009

MADRID, Spain, 28046

MADRID, Spain, 28905
Thailand

KHON KAEN, Thailand, 40002

PATHUMWAN, Thailand, 10330

PAYATHAI, Thailand, 10400

BANGKOK, Thailand, 10400

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	NV20911, 2007-004617-34
Study First Received:	February 18, 2008
Last Updated:	August 26, 2009
ClinicalTrials.gov Identifier:	NCT00623597 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Anti-Infective Agents
Sexually Transmitted Diseases, Viral
HIV Protease Inhibitors
Anti-HIV Agents
Saquinavir
Acquired Immunodeficiency Syndrome
Antiviral Agents
Immunologic Deficiency Syndromes

Protease Inhibitors
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Ritonavir
Sexually Transmitted Diseases
Retroviridae Infections

Additional relevant MeSH terms:

Anti-Infective Agents
HIV Protease Inhibitors
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Saquinavir
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Infection

Antiviral Agents
Pharmacologic Actions
Immunologic Deficiency Syndromes
Protease Inhibitors
Virus Diseases
Anti-Retroviral Agents
Ritonavir
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on September 03, 2009