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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Key information

Conditions

Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Site Reference ID/Investigator# 35862, Aichi, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lopinavir/ritonavir (Kaletra)

Drug

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Important dates

Study start: 2000
Primary completion: 2010
Study completion: 2010
First posted: Feb 26, 2010
Registry last updated: Jan 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed