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Special Investigation of Kaletra in Pregnant Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01076985
First received: February 25, 2010
Last updated: December 9, 2011
Last verified: December 2011
History of Changes

February 25, 2010
December 9, 2011
December 2000
December 2010   (final data collection date for primary outcome measure)
Number of Patients With Adverse Drug Reactions (ADRs) [ Time Frame: During pregnancy and for one year after birth ] [ Designated as safety issue: Yes ]
The number of patients (mothers and infants) with adverse drug reactions, defined as adverse events for which the causal relationship with Kaletra was something other than "not related" by the investigator (i.e., "probable," "possible," or "unclear"). ADRs are reported by preferred term and inclusive of all those reported at any visit. Although a patient may experience a particular preferred term more than once, each patient was counted only once for each preferred term.
Evaluation of adverse event (occurrence of adverse event (yes or no), date of onset, diagnosis or definite symptom, details of symptom/course/intervention, seriousness, intensity, outcome, relationship to disease and drugs used) [ Time Frame: During course of pre and post birth, and for one year after birth ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01076985 on ClinicalTrials.gov Archive Site
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Special Investigation of Kaletra in Pregnant Women
Special Investigation of Kaletra in Pregnant Women

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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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Hospital
Human Immunodeficiency Virus
Drug: Lopinavir/ritonavir (Kaletra)
Lopinavir/ritonavir (LPV/r) evaluated separately in patients who were naive to previous antiretroviral treatment and those who were not.
Other Names:
  • Lopinavir/ritonavir
  • Kaletra
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.
Intervention: Drug: Lopinavir/ritonavir (Kaletra)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Female
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No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01076985
PMOS-JAP-00-002
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Abbott
Abbott
Not Provided
Study Director: Toshiro Maeda Abbott Japan Co.,Ltd
Abbott
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP