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

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00145561
First received: September 2, 2005
Last updated: October 21, 2008
Last verified: October 2008
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


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
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

No publications provided

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
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
HIV

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Ritonavir
Saquinavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014