The Pharmacokinetic Study of Saquinavir New Tablet Formulation in HIV-infected Pregnant Women.
- Conditions
- HIV Infections
- Registration Number
- NCT00145561
- Lead Sponsor
- Radboud University Medical Center
- Brief Summary
Pharmacokinetic study of Saquinavir and Ritonavir in HIV-infected pregnant women
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 40
- HIV infected woman
- 18 - 40 years of age
- able and willing to sign Informed Consent
- pregnant for a maximum of 31 weeks
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method pharmacokinetics at week 20 and 33 of gestation and 6 weeks post partum
- Secondary Outcome Measures
Name Time Method antiviral activity safety
Trial Locations
- Locations (10)
Radboud University Medical Centre Nijmegen
🇳🇱Nijmegen, Netherlands
Erasmus Medical Centre
🇳🇱Rotterdam, Netherlands
Rijnstate Hospital
🇳🇱Arnhem, Netherlands
University of Leiden
🇳🇱Leiden, Netherlands
University of Bonn
🇩🇪Bonn, Germany
University of Cologne
🇩🇪Köln, Germany
Clinic Rajdumri Road Pathumwan
🇹🇭Bangkok, Thailand
University Hospital ''Germans Trias i Pujol''
🇪🇸Barcelona, Spain
Birmingham Heartlands & Sollihull Hospital
🇬🇧Birmingham, United Kingdom
Chelsea and Westminster Hospital
🇬🇧London, United Kingdom