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

This study has been completed.

Sponsors and Collaborators: Radboud University
Hoffmann-La Roche
Information provided by: Radboud University
ClinicalTrials.gov Identifier: NCT00145561
  Purpose

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


Condition Intervention Phase
HIV Infections
Drug: Saquinavir and Ritonavir
Phase I
Phase II

MedlinePlus related topics:   AIDS   

Drug Information available for:   Ritonavir    Saquinavir    Saquinavir mesylate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
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
Ages Eligible for Study:   18 Years to 40 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00145561

Locations
Germany
University of Cologne    
      Köln, Germany
University of Bonn    
      Bonn, Germany, 53127
Netherlands
Radboud University Medical Centre Nijmegen    
      Nijmegen, Netherlands, 6500HB
University of Leiden    
      Leiden, Netherlands, 2300RC
Erasmus Medical Centre    
      Rotterdam, Netherlands
Rijnstate Hospital    
      Arnhem, Netherlands, 6815AD
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


Responsible Party:   Radboud University Nijmegen Medical Centre ( D.M. Burger PharmD PhD, hospital pharmacist )
Study ID Numbers:   UMCN-AKF 04.02, MV19059
First Received:   September 2, 2005
Last Updated:   October 21, 2008
ClinicalTrials.gov Identifier:   NCT00145561
Health Authority:   Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
HIV  

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
Saquinavir
Ritonavir
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
HIV Protease Inhibitors
Slow Virus Diseases
Anti-HIV Agents
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Protease Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections

ClinicalTrials.gov processed this record on October 31, 2008




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