Status:
COMPLETED
The Pharmacokinetic Study of Saquinavir New Tablet Formulation in HIV-infected Pregnant Women.
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
HIV Infections
Eligibility:
FEMALE
18-40 years
Phase:
PHASE1
PHASE2
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 pregn...
Eligibility Criteria
Inclusion
- HIV infected woman
- 18 - 40 years of age
- able and willing to sign Informed Consent
- pregnant for a maximum of 31 weeks
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00145561
Start Date
August 1 2005
End Date
February 1 2008
Last Update
October 19 2020
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Bonn
Bonn, Germany, 53127
2
University of Cologne
Cologne, Germany
3
Rijnstate Hospital
Arnhem, Netherlands, 6815AD
4
University of Leiden
Leiden, Netherlands, 2300RC