At a glance
ClinicalIndex Comparison RecordN/ACompleted· 24 enrolled
Drug / intervention
Lopinavir/ritonavir (Kaletra)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Special Investigation of Kaletra in Pregnant Women
In Brief
An observational study evaluating Lopinavir/ritonavir (Kaletra) for Human Immunodeficiency Virus. Completed, enrolled 24 participants across 5 sites.
Detailed 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.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHuman Immunodeficiency Virus
CountriesJapan
Collaborators--
Timeline
N/ACompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2000
First PostedFeb 2010
Primary CompletionDec 2010
TodayJul 2026
First PostedFeb 26, 2010
Enrollment StartDec 1, 2000
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 10 yearsPosted 16.3 years ago
Interventions
Lopinavir/ritonavir (Kaletra)drug
Lopinavir/ritonavir (LPV/r) evaluated separately in patients who were naive to previous antiretroviral treatment and those who were not.