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

October 16, 2020 updated by: Radboud University Medical Center

The Pharmacokinetics of SAquinavir (Invirase New Tablet Formulation) 1,000mg + Ritonavir (Norvir) 100mg q12h in HIV-infected Pregnant Women (SARA)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bonn, Germany, 53127
        • University of Bonn
      • Köln, Germany
        • University of Cologne
  • Netherlands
      • Arnhem, Netherlands, 6815AD
        • Rijnstate Hospital
      • Leiden, Netherlands, 2300RC
        • University of Leiden
      • Nijmegen, Netherlands, 6500HB
        • Radboud University Medical Centre Nijmegen
      • Rotterdam, Netherlands
        • Erasmus Medical Centre
  • Spain
      • Barcelona, Spain, 08916
        • University Hospital ''Germans Trias i Pujol''
  • Thailand
      • Bangkok, Thailand, 10330
        • Clinic Rajdumri Road Pathumwan
  • United Kingdom
      • Birmingham, United Kingdom
        • Birmingham Heartlands & Sollihull Hospital
      • London, United Kingdom, SW10 9NH
        • Chelsea And Westminster Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
pharmacokinetics at week 20 and 33 of gestation and 6 weeks post partum

Secondary Outcome Measures

Outcome Measure
safety
antiviral activity

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

Hoffmann-La Roche

Investigators

  • Principal Investigator: David M Burger, Dr, Radboud University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

September 2, 2005

First Submitted That Met QC Criteria

September 2, 2005

First Posted (Estimate)

September 5, 2005

Study Record Updates

Last Update Posted (Actual)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 16, 2020

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMCN-AKF 04.02
  • MV19059

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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