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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Radboud University

Collaborator
Hoffmann-La Roche

Information provided by (Responsible Party)
Radboud University
ClinicalTrials.gov Identifier
NCT00145561

First received: September 2, 2005
Last updated: October 21, 2008
Last Verified: October 2008
History of Changes
Purpose

Purpose

Pharmacokinetic study of Saquinavir and Ritonavir in HIV-infected pregnant women

Condition Intervention Phase
HIV Infections

Drug : Saquinavir and Ritonavir
Phase 1
Phase 2

Study Type: Interventional
Study Design: 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)

Further study details as provided by Radboud University:

Primary Outcome Measures

  • pharmacokinetics at week 20 and 33 of gestation and 6 weeks post partum
Secondary Outcome Measures:
  • antiviral activity
  • safety

Enrollment: 40
Study Start Date: August 2005
Study Completion Date: February 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 40 Years  
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

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: NCT00145561

Locations

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
Hoffmann-La Roche

Investigators

Principal Investigator: David M Burger, Dr Radboud University
More Information

More Information


Responsible Party: D.M. Burger PharmD PhD, hospital pharmacist, Radboud University Nijmegen Medical Centre  
ClinicalTrials.gov Identifier: NCT00145561   History of Changes  
Other Study ID Numbers: UMCN-AKF 04.02  
  MV19059  
Study First Received: September 2, 2005  
Last Updated: October 21, 2008  

Keywords provided by Radboud University:

HIV

Additional relevant MeSH terms:
HIV Infections
Ritonavir
Saquinavir

ClinicalTrials.gov processed this data on October 20, 2017
This information is provided by ClinicalTrials.gov.