Special Investigation of Kaletra in Pregnant Women

• 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: Abbott
• 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

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

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