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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00145561
• Other study ID #: UMCN-AKF 04.02
• Secondary ID: MV19059
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 2005
• Est. completion date: February 2008

Study information

• Verified date: October 2008
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Saquinavir and Ritonavir

Locations

Country	Name	City	State
Germany	University of Bonn	Bonn
Germany	University of Cologne	Köln
Netherlands	Rijnstate Hospital	Arnhem
Netherlands	University of Leiden	Leiden
Netherlands	Radboud University Medical Centre Nijmegen	Nijmegen
Netherlands	Erasmus Medical Centre	Rotterdam
Spain	University Hospital ''Germans Trias i Pujol''	Barcelona
Thailand	Clinic Rajdumri Road Pathumwan	Bangkok
United Kingdom	Birmingham Heartlands & Sollihull Hospital	Birmingham
United Kingdom	Chelsea and Westminster Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	Hoffmann-La Roche

Countries where clinical trial is conducted

Germany,  Netherlands,  Spain,  Thailand,  United Kingdom, 

References & Publications (1)

van der Lugt J, Colbers A, Molto J, Hawkins D, van der Ende M, Vogel M, Wyen C, Schutz M, Koopmans P, Ruxrungtham K, Richter C, Burger D; SARA study team. The pharmacokinetics, safety and efficacy of boosted saquinavir tablets in HIV type-1-infected pregn — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pharmacokinetics at week 20 and 33 of gestation and 6 weeks post partum
Secondary	antiviral activity
Secondary	safety

External Links

•   paper