Human Immunodeficiency VirusNCT01076985
Special Investigation of Kaletra in Pregnant Women
An observational study of Human Immunodeficiency Virus, run by Abbott at 5 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- Lopinavir/ritonavir (Kaletra)
- How many people
- 24 participants
- Where
- 5 sitesJapan
- Study dates
- Dec 2000to Dec 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hospital
Who may be able to join
- All pregnant women who have received Kaletra for the treatment of HIV infection were eligible for this study
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Japan5 sites
Site Reference ID/Investigator# 35862
Aichi
Site Reference ID/Investigator# 35863
Okayama
Site Reference ID/Investigator# 35864
Osaka
Site Reference ID/Investigator# 35865
Tokyo
Site Reference ID/Investigator# 5326
Tokyo
About this study
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.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- Lopinavir/ritonavir (Kaletra)
- Keywords
- Human Immunodeficiency Virus
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lopinavir/ritonavir (Kaletra)Drug
Also called Lopinavir/ritonavir, Kaletra
Lopinavir/ritonavir (LPV/r) evaluated separately in patients who were naive to previous antiretroviral treatment and those who were not.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Lopinavir/ritonavir (Kaletra) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During pregnancy and for one year after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2010 (estimated)
- Study startDec 2000
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Toshiro Maeda, Study director, Abbott Japan Co.,Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01076985
- Sponsor's protocol ID
- PMOS-JAP-00-002
- Status last verified
- Dec 2011
- First submitted
- 25 Feb 2010
- Last updated
- 18 Jan 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Investigation of Kaletra in Pregnant Women
- ClinicalTrials.gov ID
- NCT01076985
- Acronym / sponsor ID
- PMOS-JAP-00-002
- Conditions
- Human Immunodeficiency Virus
- Keywords
- Human Immunodeficiency Virus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Dec 2000
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 26 Feb 2010 (estimated)
- Results
- Posted 18 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lopinavir/ritonavir group | – | Drug: Lopinavir/ritonavir (Kaletra)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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospital
Key inclusion criteria (1 listed)
- All pregnant women who have received Kaletra for the treatment of HIV infection were eligible for this study
Key exclusion criteria (3 listed)
- Contraindications according to the Package Insert:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lopinavir/ritonavir (Kaletra)Also: Lopinavir/ritonavir, KaletraLopinavir/ritonavir (LPV/r) evaluated separately in patients who were naive to previous antiretroviral treatment and those who were not. | Drug | Lopinavir/ritonavir group |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Toshiro Maeda study director
Abbott Japan Co.,Ltd
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Immunodeficiency Virus, run by Abbott at 5 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Adverse Drug Reactions (ADRs) (time frame: During pregnancy and for one year after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2012.