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)

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.

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

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.