Special Investigation of Kaletra in Pregnant Women
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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. |
| ClinicalTrials.gov Identifier: NCT01076985 |
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Recruitment Status
:
Completed
First Posted
: February 26, 2010
Results First Posted
: January 18, 2012
Last Update Posted
: January 18, 2012
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Sponsor:
Abbott
Information provided by (Responsible Party):
Abbott
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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 |
| Actual Primary Completion Date : | December 2010 |
| Actual 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 |
|---|---|
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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.
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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:
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Primary Outcome Measures
:
- 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
Hospital
Criteria
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 ClinicalTrials.gov identifier (NCT number): NCT01076985
Locations
| Japan | |
| 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
Abbott
Investigators
| Study Director: | Toshiro Maeda | Abbott Japan Co.,Ltd |
| Responsible Party: | Abbott |
| ClinicalTrials.gov 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:
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Human Immunodeficiency Virus |
Additional relevant MeSH terms:
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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 Ritonavir |
Lopinavir 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 |