Trial Outcomes & Findings for Special Investigation of Kaletra in Pregnant Women (NCT NCT01076985)

Last Updated: 2012-01-18

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

24 participants

Primary outcome timeframe

During pregnancy and for one year after birth

Results posted on

2012-01-18

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Special Investigation of Kaletra in Pregnant Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lopinavir/Ritonavir Group n=24 Participants 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.
Age Continuous	30 years STANDARD_DEVIATION 5.7 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment Japan	24 participants n=5 Participants

PRIMARY outcome

Timeframe: During pregnancy and for one year after birth

Population: All available observed data for all participants and their resulting infants/live births are included.

Outcome measures

Outcome measures
Measure	Lopinavir/Ritonavir n=24 Participants 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.	Infants n=21 Participants Infants from live births of the pregnant women who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection and participated in this noninterventional, post-marketing observational study.
Number of Patients With Adverse Drug Reactions (ADRs) Anemia	2 participants	5 participants
Number of Patients With Adverse Drug Reactions (ADRs) Hypercholesterolemia	1 participants	0 participants
Number of Patients With Adverse Drug Reactions (ADRs) Hyperlipidemia	1 participants	0 participants
Number of Patients With Adverse Drug Reactions (ADRs) Diarrhea	1 participants	0 participants
Number of Patients With Adverse Drug Reactions (ADRs) Nausea	2 participants	0 participants
Number of Patients With Adverse Drug Reactions (ADRs) Rash	1 participants	1 participants
Number of Patients With Adverse Drug Reactions (ADRs) Abortion missed	1 participants	0 participants
Number of Patients With Adverse Drug Reactions (ADRs) Premature labor	1 participants	0 participants
Number of Patients With Adverse Drug Reactions (ADRs) Threatened labor	1 participants	0 participants
Number of Patients With Adverse Drug Reactions (ADRs) Neutropenia	0 participants	1 participants
Number of Patients With Adverse Drug Reactions (ADRs) Hypoglycemia	0 participants	1 participants
Number of Patients With Adverse Drug Reactions (ADRs) Cardio-respiratory arrest	0 participants	1 participants
Number of Patients With Adverse Drug Reactions (ADRs) Apnea	0 participants	1 participants
Number of Patients With Adverse Drug Reactions (ADRs) Neonatal respiratory distress syndrome	0 participants	1 participants
Number of Patients With Adverse Drug Reactions (ADRs) Transient tachypnea of the newborn	0 participants	1 participants
Number of Patients With Adverse Drug Reactions (ADRs) Small for dates baby	0 participants	1 participants
Number of Patients With Adverse Drug Reactions (ADRs) Pyrexia	0 participants	1 participants

Adverse Events

Lopinavir/Ritonavir Group

Serious events: 3 serious events

Other events: 11 other events

Deaths: 0 deaths

Infants

Serious events: 3 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Lopinavir/Ritonavir Group n=24 participants at risk 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.	Infants n=21 participants at risk Infants from live births of the pregnant women who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection who participated in this noninterventional, post-marketing observational study.
Pregnancy, puerperium and perinatal conditions Abortion missed	4.2% 1/24 • All adverse events that occurred during pregnancy and in their infants for up to one year after birth were reported.	0.00% 0/21 • All adverse events that occurred during pregnancy and in their infants for up to one year after birth were reported.
Pregnancy, puerperium and perinatal conditions Premature labor	4.2% 1/24 • All adverse events that occurred during pregnancy and in their infants for up to one year after birth were reported.	0.00% 0/21 • All adverse events that occurred during pregnancy and in their infants for up to one year after birth were reported.
Pregnancy, puerperium and perinatal conditions Threatened labor	4.2% 1/24 • All adverse events that occurred during pregnancy and in their infants for up to one year after birth were reported.	0.00% 0/21 • All adverse events that occurred during pregnancy and in their infants for up to one year after birth were reported.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/24 • All adverse events that occurred during pregnancy and in their infants for up to one year after birth were reported.	4.8% 1/21 • All adverse events that occurred during pregnancy and in their infants for up to one year after birth were reported.
Respiratory, thoracic and mediastinal disorders Neonatal respiratory distress syndrome	0.00% 0/24 • All adverse events that occurred during pregnancy and in their infants for up to one year after birth were reported.	4.8% 1/21 • All adverse events that occurred during pregnancy and in their infants for up to one year after birth were reported.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	0.00% 0/24 • All adverse events that occurred during pregnancy and in their infants for up to one year after birth were reported.	4.8% 1/21 • All adverse events that occurred during pregnancy and in their infants for up to one year after birth were reported.
Pregnancy, puerperium and perinatal conditions Small for dates baby	0.00% 0/24 • All adverse events that occurred during pregnancy and in their infants for up to one year after birth were reported.	4.8% 1/21 • All adverse events that occurred during pregnancy and in their infants for up to one year after birth were reported.

Other adverse events

Additional Information

Global Medical Services

Abbott

Phone: 800-633-9110

Results disclosure agreements

Principal investigator is a sponsor employee Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
Publication restrictions are in place

Restriction type: OTHER

Measure	Lopinavir/Ritonavir Group n=24 participants at risk 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.	Infants n=21 participants at risk Infants from live births of the pregnant women who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection who participated in this noninterventional, post-marketing observational study.
Metabolism and nutrition disorders Hypercholesterolemia	4.2% 1/24 • All adverse events that occurred during pregnancy and in their infants for up to one year after birth were reported.	0.00% 0/21 • All adverse events that occurred during pregnancy and in their infants for up to one year after birth were reported.
Metabolism and nutrition disorders Hyperlipidemia	4.2% 1/24 • All adverse events that occurred during pregnancy and in their infants for up to one year after birth were reported.	0.00% 0/21 • All adverse events that occurred during pregnancy and in their infants for up to one year after birth were reported.
Psychiatric disorders Mental disorder	4.2% 1/24 • All adverse events that occurred during pregnancy and in their infants for up to one year after birth were reported.	0.00% 0/21 • All adverse events that occurred during pregnancy and in their infants for up to one year after birth were reported.
Gastrointestinal disorders Diarrhea	4.2% 1/24 • All adverse events that occurred during pregnancy and in their infants for up to one year after birth were reported.	0.00% 0/21 • All adverse events that occurred during pregnancy and in their infants for up to one year after birth were reported.
Gastrointestinal disorders Nausea	8.3% 2/24 • All adverse events that occurred during pregnancy and in their infants for up to one year after birth were reported.	0.00% 0/21 • All adverse events that occurred during pregnancy and in their infants for up to one year after birth were reported.
Skin and subcutaneous tissue disorders Rash	4.2% 1/24 • All adverse events that occurred during pregnancy and in their infants for up to one year after birth were reported.	4.8% 1/21 • All adverse events that occurred during pregnancy and in their infants for up to one year after birth were reported.
Reproductive system and breast disorders Breast enlargement	4.2% 1/24 • All adverse events that occurred during pregnancy and in their infants for up to one year after birth were reported.	0.00% 0/21 • All adverse events that occurred during pregnancy and in their infants for up to one year after birth were reported.
Blood and lymphatic system disorders Neutropenia	0.00% 0/24 • All adverse events that occurred during pregnancy and in their infants for up to one year after birth were reported.	4.8% 1/21 • All adverse events that occurred during pregnancy and in their infants for up to one year after birth were reported.
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/24 • All adverse events that occurred during pregnancy and in their infants for up to one year after birth were reported.	9.5% 2/21 • All adverse events that occurred during pregnancy and in their infants for up to one year after birth were reported.
Respiratory, thoracic and mediastinal disorders Apnea	0.00% 0/24 • All adverse events that occurred during pregnancy and in their infants for up to one year after birth were reported.	4.8% 1/21 • All adverse events that occurred during pregnancy and in their infants for up to one year after birth were reported.
Respiratory, thoracic and mediastinal disorders Transient tachypnea of the newborn	0.00% 0/24 • All adverse events that occurred during pregnancy and in their infants for up to one year after birth were reported.	4.8% 1/21 • All adverse events that occurred during pregnancy and in their infants for up to one year after birth were reported.
Pregnancy, puerperium and perinatal conditions Large for dates baby	0.00% 0/24 • All adverse events that occurred during pregnancy and in their infants for up to one year after birth were reported.	4.8% 1/21 • All adverse events that occurred during pregnancy and in their infants for up to one year after birth were reported.
General disorders Pyrexia	0.00% 0/24 • All adverse events that occurred during pregnancy and in their infants for up to one year after birth were reported.	4.8% 1/21 • All adverse events that occurred during pregnancy and in their infants for up to one year after birth were reported.
Investigations Haemoglobin decreased	0.00% 0/24 • All adverse events that occurred during pregnancy and in their infants for up to one year after birth were reported.	9.5% 2/21 • All adverse events that occurred during pregnancy and in their infants for up to one year after birth were reported.
Blood and lymphatic system disorders Anemia	25.0% 6/24 • All adverse events that occurred during pregnancy and in their infants for up to one year after birth were reported.	47.6% 10/21 • All adverse events that occurred during pregnancy and in their infants for up to one year after birth were reported.