Special Investigation of Kaletra in Pregnant Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01076985
Recruitment Status : Completed
First Posted : February 26, 2010
Results First Posted : January 18, 2012
Last Update Posted : January 18, 2012
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment
Human Immunodeficiency Virus Drug: Lopinavir/ritonavir (Kaletra)

Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Investigation of Kaletra in Pregnant Women
Study Start Date : December 2000
Primary Completion Date : December 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Group/Cohort Intervention/treatment
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.
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

Primary Outcome Measures :
  1. Number of Patients With Adverse Drug Reactions (ADRs) [ Time Frame: During pregnancy and for one year after birth ]
    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.

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01076985

Site Reference ID/Investigator# 35862
Aichi, Japan
Site Reference ID/Investigator# 35863
Okayama, Japan
Site Reference ID/Investigator# 35864
Osaka, Japan
Site Reference ID/Investigator# 35865
Tokyo, Japan
Site Reference ID/Investigator# 5326
Tokyo, Japan
Sponsors and Collaborators
Study Director: Toshiro Maeda Abbott Japan Co.,Ltd

Responsible Party: Abbott Identifier: NCT01076985     History of Changes
Other Study ID Numbers: PMOS-JAP-00-002
First Posted: February 26, 2010    Key Record Dates
Results First Posted: January 18, 2012
Last Update Posted: January 18, 2012
Last Verified: December 2011

Keywords provided by Abbott:
Human Immunodeficiency Virus

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors