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Trial record 5 of 244 for:    "Viral Infectious Disease" | "Lopinavir"

Special Investigation of Kaletra in Pregnant Women

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ClinicalTrials.gov Identifier: NCT01076985
Recruitment Status : Completed
First Posted : February 26, 2010
Results First Posted : January 18, 2012
Last Update Posted : January 18, 2012
Sponsor:
Information provided by (Responsible Party):
Abbott

Tracking Information
First Submitted Date February 25, 2010
First Posted Date February 26, 2010
Results First Submitted Date December 9, 2011
Results First Posted Date January 18, 2012
Last Update Posted Date January 18, 2012
Study Start Date December 2000
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 9, 2011)
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.
Original Primary Outcome Measures
 (submitted: February 25, 2010)
Evaluation of adverse event (occurrence of adverse event (yes or no), date of onset, diagnosis or definite symptom, details of symptom/course/intervention, seriousness, intensity, outcome, relationship to disease and drugs used) [ Time Frame: During course of pre and post birth, and for one year after birth ]
Change History Complete list of historical versions of study NCT01076985 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Special Investigation of Kaletra in Pregnant Women
Official Title Special Investigation of Kaletra in Pregnant Women
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Hospital
Condition Human Immunodeficiency Virus
Intervention 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
Study Groups/Cohorts 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.
Intervention: Drug: Lopinavir/ritonavir (Kaletra)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 24, 2011)
24
Original Estimated Enrollment
 (submitted: February 25, 2010)
30
Actual Study Completion Date December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT01076985
Other Study ID Numbers PMOS-JAP-00-002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Abbott
Study Sponsor Abbott
Collaborators Not Provided
Investigators
Study Director: Toshiro Maeda Abbott Japan Co.,Ltd
PRS Account Abbott
Verification Date December 2011