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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lopinavir/ritonavir (Kaletra) | Drug | Lopinavir/ritonavir (LPV/r) evaluated separately in patients who were naive to previous antiretroviral treatment and those who were not. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Adverse Drug Reactions (ADRs) | 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. | During pregnancy and for one year after birth |
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Inclusion Criteria:
Exclusion Criteria:
Contraindications according to the Package Insert:
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Hospital
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| Name | Affiliation | Role |
|---|---|---|
| Toshiro Maeda | Abbott Japan Co.,Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 35862 | Aichi | Japan | ||||
| Site Reference ID/Investigator# 35863 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Adverse Drug Reactions (ADRs) | 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. | All available observed data for all participants and their resulting infants/live births are included. | Posted | Number | participants | During pregnancy and for one year after birth |
|
All adverse events that occurred during pregnancy and in their infants for up to one year after birth were reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abortion missed | Pregnancy, puerperium and perinatal conditions | MedDRA (13.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | Abbott | 800-633-9110 |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D061466 | Lopinavir |
| D019438 | Ritonavir |
| C558899 | lopinavir-ritonavir drug combination |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Okayama |
| Japan |
| Site Reference ID/Investigator# 35864 | Osaka | Japan |
| Site Reference ID/Investigator# 35865 | Tokyo | Japan |
| Site Reference ID/Investigator# 5326 | Tokyo | Japan |
| years |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Infants | 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. |
|
|
| 3 |
| 24 |
| 11 |
| 24 |
| EG001 | Infants | 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. | 3 | 21 | 10 | 21 |
| Premature labor | Pregnancy, puerperium and perinatal conditions | MedDRA (13.1) | Non-systematic Assessment |
|
| Threatened labor | Pregnancy, puerperium and perinatal conditions | MedDRA (13.1) | Non-systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Neonatal respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Small for dates baby | Pregnancy, puerperium and perinatal conditions | MedDRA (13.1) | Non-systematic Assessment |
|
| Hypercholesterolemia | Metabolism and nutrition disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Hyperlipidemia | Metabolism and nutrition disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Mental disorder | Psychiatric disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Breast enlargement | Reproductive system and breast disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Apnea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Transient tachypnea of the newborn | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Large for dates baby | Pregnancy, puerperium and perinatal conditions | MedDRA (13.1) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA (13.1) | Non-systematic Assessment |
|
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.
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D013844 |
| Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |