The Pharmacokinetic Study of Saquinavir New Tablet Formulation in HIV-infected Pregnant Women.
The Pharmacokinetics of SAquinavir (Invirase New Tablet Formulation) 1,000mg + Ritonavir (Norvir) 100mg q12h in HIV-infected Pregnant Women (SARA)
2 other identifiers
interventional
40
5 countries
10
Brief Summary
Pharmacokinetic study of Saquinavir and Ritonavir in HIV-infected pregnant women
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 hiv-infections
Started Aug 2005
Typical duration for phase_1 hiv-infections
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 2, 2005
CompletedFirst Posted
Study publicly available on registry
September 5, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedOctober 19, 2020
October 1, 2008
2.4 years
September 2, 2005
October 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
pharmacokinetics at week 20 and 33 of gestation and 6 weeks post partum
Secondary Outcomes (2)
antiviral activity
safety
Interventions
Eligibility Criteria
You may qualify if:
- HIV infected woman
- years of age
- able and willing to sign Informed Consent
- pregnant for a maximum of 31 weeks
You may not qualify if:
- history of sensitivity/idiosyncrasy to the drug
- relevant history of interference with drug metabolism
- inability to understand trial procedures
- abnormal specific serum levels
- use of specific concomitant medications
- active hepatobiliary or hepatic disease
- previous failure of saquinavir/ritonavir regimen
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Radboud University Medical Centerlead
- Hoffmann-La Rochecollaborator
Study Sites (10)
University of Bonn
Bonn, 53127, Germany
University of Cologne
Cologne, Germany
Rijnstate Hospital
Arnhem, 6815AD, Netherlands
University of Leiden
Leiden, 2300RC, Netherlands
Radboud University Medical Centre Nijmegen
Nijmegen, 6500HB, Netherlands
Erasmus Medical Centre
Rotterdam, Netherlands
University Hospital ''Germans Trias i Pujol''
Barcelona, 08916, Spain
Clinic Rajdumri Road Pathumwan
Bangkok, 10330, Thailand
Birmingham Heartlands & Sollihull Hospital
Birmingham, United Kingdom
Chelsea and Westminster Hospital
London, SW10 9NH, United Kingdom
Related Publications (1)
van der Lugt J, Colbers A, Molto J, Hawkins D, van der Ende M, Vogel M, Wyen C, Schutz M, Koopmans P, Ruxrungtham K, Richter C, Burger D; SARA study team. The pharmacokinetics, safety and efficacy of boosted saquinavir tablets in HIV type-1-infected pregnant women. Antivir Ther. 2009;14(3):443-50.
PMID: 19474478RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David M Burger, Dr
Radboud University Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 2, 2005
First Posted
September 5, 2005
Study Start
August 1, 2005
Primary Completion
January 1, 2008
Study Completion
February 1, 2008
Last Updated
October 19, 2020
Record last verified: 2008-10