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

R

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)

Trial contacts and locations

10

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Data sourced from clinicaltrials.gov

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