Human Immunodeficiency Virus
Conditions
Keywords
Human Immunodeficiency Virus
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.
Interventions
Lopinavir/ritonavir (LPV/r) evaluated separately in patients who were naive to previous antiretroviral treatment and those who were not.
Sponsors
Abbott
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Adverse Drug Reactions (ADRs) | 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. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 24 |
| Total | 24 |
Baseline characteristics
| Characteristic | Lopinavir/Ritonavir Group |
|---|---|
| Age Continuous | 30 years STANDARD_DEVIATION 5.7 |
| Region of Enrollment Japan | 24 participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 24 | 10 / 21 |
| serious Total, serious adverse events | 3 / 24 | 3 / 21 |
Outcome results
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.
Time frame: During pregnancy and for one year after birth
Population: All available observed data for all participants and their resulting infants/live births are included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lopinavir/Ritonavir | Number of Patients With Adverse Drug Reactions (ADRs) | Anemia | 2 participants |
| Lopinavir/Ritonavir | Number of Patients With Adverse Drug Reactions (ADRs) | Neutropenia | 0 participants |
| Lopinavir/Ritonavir | Number of Patients With Adverse Drug Reactions (ADRs) | Diarrhea | 1 participants |
| Lopinavir/Ritonavir | Number of Patients With Adverse Drug Reactions (ADRs) | Hypoglycemia | 0 participants |
| Lopinavir/Ritonavir | Number of Patients With Adverse Drug Reactions (ADRs) | Hypercholesterolemia | 1 participants |
| Lopinavir/Ritonavir | Number of Patients With Adverse Drug Reactions (ADRs) | Cardio-respiratory arrest | 0 participants |
| Lopinavir/Ritonavir | Number of Patients With Adverse Drug Reactions (ADRs) | Rash | 1 participants |
| Lopinavir/Ritonavir | Number of Patients With Adverse Drug Reactions (ADRs) | Apnea | 0 participants |
| Lopinavir/Ritonavir | Number of Patients With Adverse Drug Reactions (ADRs) | Hyperlipidemia | 1 participants |
| Lopinavir/Ritonavir | Number of Patients With Adverse Drug Reactions (ADRs) | Neonatal respiratory distress syndrome | 0 participants |
| Lopinavir/Ritonavir | Number of Patients With Adverse Drug Reactions (ADRs) | Abortion missed | 1 participants |
| Lopinavir/Ritonavir | Number of Patients With Adverse Drug Reactions (ADRs) | Transient tachypnea of the newborn | 0 participants |
| Lopinavir/Ritonavir | Number of Patients With Adverse Drug Reactions (ADRs) | Premature labor | 1 participants |
| Lopinavir/Ritonavir | Number of Patients With Adverse Drug Reactions (ADRs) | Small for dates baby | 0 participants |
| Lopinavir/Ritonavir | Number of Patients With Adverse Drug Reactions (ADRs) | Threatened labor | 1 participants |
| Lopinavir/Ritonavir | Number of Patients With Adverse Drug Reactions (ADRs) | Pyrexia | 0 participants |
| Lopinavir/Ritonavir | Number of Patients With Adverse Drug Reactions (ADRs) | Nausea | 2 participants |
| Infants | Number of Patients With Adverse Drug Reactions (ADRs) | Pyrexia | 1 participants |
| Infants | Number of Patients With Adverse Drug Reactions (ADRs) | Diarrhea | 0 participants |
| Infants | Number of Patients With Adverse Drug Reactions (ADRs) | Anemia | 5 participants |
| Infants | Number of Patients With Adverse Drug Reactions (ADRs) | Abortion missed | 0 participants |
| Infants | Number of Patients With Adverse Drug Reactions (ADRs) | Premature labor | 0 participants |
| Infants | Number of Patients With Adverse Drug Reactions (ADRs) | Hypercholesterolemia | 0 participants |
| Infants | Number of Patients With Adverse Drug Reactions (ADRs) | Hyperlipidemia | 0 participants |
| Infants | Number of Patients With Adverse Drug Reactions (ADRs) | Nausea | 0 participants |
| Infants | Number of Patients With Adverse Drug Reactions (ADRs) | Rash | 1 participants |
| Infants | Number of Patients With Adverse Drug Reactions (ADRs) | Threatened labor | 0 participants |
| Infants | Number of Patients With Adverse Drug Reactions (ADRs) | Neutropenia | 1 participants |
| Infants | Number of Patients With Adverse Drug Reactions (ADRs) | Hypoglycemia | 1 participants |
| Infants | Number of Patients With Adverse Drug Reactions (ADRs) | Cardio-respiratory arrest | 1 participants |
| Infants | Number of Patients With Adverse Drug Reactions (ADRs) | Apnea | 1 participants |
| Infants | Number of Patients With Adverse Drug Reactions (ADRs) | Neonatal respiratory distress syndrome | 1 participants |
| Infants | Number of Patients With Adverse Drug Reactions (ADRs) | Transient tachypnea of the newborn | 1 participants |
| Infants | Number of Patients With Adverse Drug Reactions (ADRs) | Small for dates baby | 1 participants |