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

Radboud University Medical Center40 enrolled

Overview

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

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV Infections

Interventions

Saquinavir and RitonavirDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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)

University of Bonn

Bonn, Germany

University of Cologne

Cologne, Germany

Rijnstate Hospital

Arnhem, Netherlands

University of Leiden

Leiden, Netherlands

Outcomes

Primary Outcomes

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

Secondary Outcomes

antiviral activity

safety

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.