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

NCT00145561

CompletedPhase 1, Phase 2

Sponsor: Radboud University Medical Center

Conditions: HIV Infections

Interventions: Saquinavir and Ritonavir

Countries: Germany, Netherlands, Spain, Thailand, United Kingdom

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

Eligibility overview

Sex: FEMALE

Age: 18 Years to 40 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (10)

Bonn, Germany
Cologne, Germany
Arnhem, Netherlands
Leiden, Netherlands
Nijmegen, Netherlands
Rotterdam, Netherlands
Barcelona, Spain
Bangkok, Thailand
Birmingham, United Kingdom
London, United Kingdom