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.

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