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

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00145561
First received: September 2, 2005
Last updated: October 21, 2008
Last verified: October 2008

September 2, 2005
October 21, 2008
August 2005
January 2008   (final data collection date for primary outcome measure)
pharmacokinetics at week 20 and 33 of gestation and 6 weeks post partum
  • * pharmacokinetics at week
  • - 20 and
  • - 33 of gestation and
  • - 6 weeks post partum
Complete list of historical versions of study NCT00145561 on ClinicalTrials.gov Archive Site
  • antiviral activity
  • safety
  • * antiviral activity
  • * safety
Not Provided
Not Provided
 
The Pharmacokinetic Study of Saquinavir New Tablet Formulation in HIV-Infected Pregnant Women.
The Pharmacokinetics of SAquinavir (Invirase New Tablet Formulation) 1,000mg + Ritonavir (Norvir) 100mg q12h in HIV-Infected Pregnant Women (SARA)

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Drug: Saquinavir and Ritonavir
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
February 2008
January 2008   (final data collection date for primary outcome measure)

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
Female
18 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Netherlands,   Spain,   Thailand,   United Kingdom
 
NCT00145561
UMCN-AKF 04.02, MV19059
No
D.M. Burger PharmD PhD, hospital pharmacist, Radboud University Nijmegen Medical Centre
Radboud University
Hoffmann-La Roche
Principal Investigator: David M Burger, Dr Radboud University
Radboud University
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP