Special Investigation of Kaletra in Pregnant Women - Full Text View

Purpose

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	Intervention
Human Immunodeficiency Virus	Drug: Lopinavir/ritonavir (Kaletra)


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Special Investigation of Kaletra in Pregnant Women

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Ritonavir Lopinavir

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

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.


Enrollment:	24
Study Start Date:	December 2000
Study Completion Date:	December 2010
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Genders 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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information


Responsible Party:	Abbott
ClinicalTrials.gov Identifier:	NCT01076985 History of Changes
Other Study ID Numbers:	PMOS-JAP-00-002
Study First Received:	February 25, 2010
Results First Received:	December 9, 2011
Last Updated:	December 9, 2011
Health Authority:	Japan: Ministry of Health, Labor and Welfare

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 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

ClinicalTrials.gov processed this record on September 30, 2016