The Pharmacokinetic Study of Saquinavir New Tablet Formulation in HIV-infected Pregnant Women.
NCT ID: NCT00145561
Last Updated: 2020-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2005-08-31
2008-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Saquinavir/Ritonavir in Liver-Impaired Patients With HIV Infection.
NCT00435929
Pharmacokinetics of Atazanavir/Ritonavir in HIV-1 Infected Pregnant Women
NCT00326716
A Single-arm, Open-label, Study to Assess the Pharmacokinetics of Darunavir and Ritonavir, Darunavir and Cobicistat, Etravirine, and Rilpivirine in HIV-1 Infected Pregnant Women
NCT00855335
Pharmacokinetics of Generic Lopinavir/Ritonavir in Pregnant Women
NCT00621166
The Pharmacokinetics of Double Boosted Protease Inhibitors in Antiretroviral-naive HIV-1 Infected Patients
NCT00400738
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Saquinavir and Ritonavir
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 18 - 40 years of age
* able and willing to sign Informed Consent
* pregnant for a maximum of 31 weeks
Exclusion Criteria
* 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
18 Years
40 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hoffmann-La Roche
INDUSTRY
Radboud University Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Radboud University Nijmegen Medical Centre
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
David M Burger, Dr
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Bonn
Bonn, , Germany
University of Cologne
Cologne, , Germany
Rijnstate Hospital
Arnhem, , Netherlands
University of Leiden
Leiden, , Netherlands
Radboud University Medical Centre Nijmegen
Nijmegen, , Netherlands
Erasmus Medical Centre
Rotterdam, , Netherlands
University Hospital ''Germans Trias i Pujol''
Barcelona, , Spain
Clinic Rajdumri Road Pathumwan
Bangkok, , Thailand
Birmingham Heartlands & Sollihull Hospital
Birmingham, , United Kingdom
Chelsea and Westminster Hospital
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MV19059
Identifier Type: -
Identifier Source: secondary_id
UMCN-AKF 04.02
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.