Special Investigation of Kaletra in Pregnant Women

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-12-31

Study Completion Date

2010-12-31

Brief Summary

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This non-interventional, post-marketing observational study was conducted to obtain safety data from the use of lopinavir/ritonavir (Kaletra), in clinical practice, in pregnant women and their children in Japan.

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Detailed Description

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Conditions

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Human Immunodeficiency Virus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Lopinavir/ritonavir group

All pregnant women in this noninterventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.

Lopinavir/ritonavir (Kaletra)

Intervention Type DRUG

Lopinavir/ritonavir (LPV/r) evaluated separately in patients who were naive to previous antiretroviral treatment and those who were not.

Interventions

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Lopinavir/ritonavir (Kaletra)

Lopinavir/ritonavir (LPV/r) evaluated separately in patients who were naive to previous antiretroviral treatment and those who were not.

Intervention Type DRUG

Other Intervention Names

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Lopinavir/ritonavir Kaletra

Eligibility Criteria

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Inclusion Criteria

* All pregnant women who have received Kaletra for the treatment of HIV infection were eligible for this study

Exclusion Criteria

* Contraindications according to the Package Insert:

* Patients with a history of hypersensitivity to any ingredient of Kaletra
* Patients who are receiving pimozide, cisapride, ergotamine tartrate, dihydroergotamine mesylate, ergometrine maleate, methylergometrine maleate, midazolam, triazolam, vardenafil hydrochloride hydrate, boriconazol

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No