Clinical trial NCT00145561: The Pharmacokinetic Study of Saquinavir New Tablet Formulation in HIV-infected Pregnant Women.
Official title: The Pharmacokinetics of SAquinavir (Invirase New Tablet Formulation) 1,000mg + Ritonavir (Norvir) 100mg q12h in HIV-infected Pregnant Women (SARA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: HIV Infections
Keywords: HIV
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
First posted: 2005-09-05
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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

Primary outcomes:
measure: pharmacokinetics at week 20 and 33 of gestation and 6 weeks post partum
Secondary outcomes:
measure: antiviral activity
measure: safety
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University of Bonn
city: Köln
country: Germany
facility: University of Cologne
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
city: Leiden
country: Netherlands
facility: University of Leiden
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Centre Nijmegen
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Centre
city: Barcelona
country: Spain
facility: University Hospital ''Germans Trias i Pujol''
city: Bangkok
country: Thailand
facility: Clinic Rajdumri Road Pathumwan
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands & Sollihull Hospital
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital
Study officials:
affiliation: Radboud University Medical Center
name: David M Burger, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 pregnant women. Antivir Ther. 2009;14(3):443-50.