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The Pharmacokinetic Study of Saquinavir New Tablet Formulation in HIV-infected Pregnant Women.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00145561
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : October 19, 2020
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
Radboud University Medical Center

Study Description
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Brief Summary:
Pharmacokinetic study of Saquinavir and Ritonavir in HIV-infected pregnant women

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Saquinavir and Ritonavir Phase 1 Phase 2

Detailed Description:
It is generally accepted that HIV-infected pregnant women should receive treatment to prevent the transmission of HIV from mother-to-child.The (relative) contra-indications for the NNRTIs during pregnancy make a PI based regimen the most rational choice. Based on several experiences and investigations it is expected that saquinavir will play a role as a component of tripe drug regimens for HIV-infected pregnant women. Since the bid dose regimen of 1,000mg saquinavir and 100mg ritonavir is approved by the regulatory authorities and with the availability of a new 500mg tablet formulation of saquinavir,there is a need for a well-designed pharmacokinetic trial using the new 500mg saquinavir tablet formulation in the above mentioned dose.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Pharmacokinetics of SAquinavir (Invirase New Tablet Formulation) 1,000mg + Ritonavir (Norvir) 100mg q12h in HIV-infected Pregnant Women (SARA)
Study Start Date : August 2005
Actual Primary Completion Date : January 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. pharmacokinetics at week 20 and 33 of gestation and 6 weeks post partum

Secondary Outcome Measures :
  1. antiviral activity
  2. safety

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV infected woman
  • 18 - 40 years of age
  • able and willing to sign Informed Consent
  • pregnant for a maximum of 31 weeks

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00145561


Locations
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Germany
University of Bonn
Bonn, Germany, 53127
University of Cologne
Köln, Germany
Netherlands
Rijnstate Hospital
Arnhem, Netherlands, 6815AD
University of Leiden
Leiden, Netherlands, 2300RC
Radboud University Medical Centre Nijmegen
Nijmegen, Netherlands, 6500HB
Erasmus Medical Centre
Rotterdam, Netherlands
Spain
University Hospital ''Germans Trias i Pujol''
Barcelona, Spain, 08916
Thailand
Clinic Rajdumri Road Pathumwan
Bangkok, Thailand, 10330
United Kingdom
Birmingham Heartlands & Sollihull Hospital
Birmingham, United Kingdom
Chelsea and Westminster Hospital
London, United Kingdom, SW10 9NH
Sponsors and Collaborators
Radboud University Medical Center
Hoffmann-La Roche
Investigators
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Principal Investigator: David M Burger, Dr Radboud University Medical Center
More Information
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Additional Information:
paper  This link exits the ClinicalTrials.gov site

Publications of Results:

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Responsible Party: D.M. Burger PharmD PhD, hospital pharmacist, Radboud University Nijmegen Medical Centre
ClinicalTrials.gov Identifier: NCT00145561    
Other Study ID Numbers: UMCN-AKF 04.02
MV19059
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2008
Keywords provided by Radboud University Medical Center:
HIV
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ritonavir
 Saquinavir
HIV Protease Inhibitors
Viral Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors