Special Investigation of Kaletra in Pregnant Women

Completed

• Conditions: Human Immunodeficiency Virus
• Interventions: Drug: Lopinavir/ritonavir (Kaletra)

• Registration Number: NCT01076985
• Lead Sponsor: Abbott

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-12
• Study First Submitted: 2010-02-25
• Study First Submitted QC: 2010-02-25
• Study First Posted: 2010-02-26
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-12
• Results First Submitted: 2011-12-09
• Results First Submitted QC: 2011-12-09
• Last Update Submitted: 2011-12-09
• Results First Posted: 2012-01-18
• Last Update Posted: 2012-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lopinavir/ritonavir group	Lopinavir/ritonavir (Kaletra)	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.

Primary Outcome Measures

Name	Time	Method
Number of Patients With Adverse Drug Reactions (ADRs)	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.

Trial Locations

Locations (5)

Site Reference ID/Investigator# 35862; 🇯🇵 Aichi, Japan

Site Reference ID/Investigator# 35864; 🇯🇵 Osaka, Japan

Site Reference ID/Investigator# 35863; 🇯🇵 Okayama, Japan

Site Reference ID/Investigator# 35865; 🇯🇵 Tokyo, Japan

Site Reference ID/Investigator# 5326; 🇯🇵 Tokyo, Japan