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

Radboud University Medical Center

Status and phase: Completed; Phase 2; Phase 1

Conditions: HIV Infections

Treatments: Drug: Saquinavir and Ritonavir

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00145561

MV19059

UMCN-AKF 04.02

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)