HIV InfectionsNCT01375881
Non-interventional Study on Use of Darunavir With Ritonavir in Clinical Practice
An observational study of HIV Infections, run by Janssen-Cilag S.p.A..
Trial summary
The purpose of this non-interventional study is a description of use of darunavir in daily practice, in retrospective and perspective manner. Darunavir will be prescribed in the usual manner and in accordance with the terms of marketing authorization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- darunavir/ritonavir plus background regimen
- Type of treatment
- Pill or oral medicine
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient using darunavir and ritonavir in clinical practice according to label in Italy. Both naive and experienced patients are allowed to enter the study
Who may be able to join
- Eligible for inclusion in this non-interventional study are adult patients in need of treatment with darunavir according to Italian label or already in treatment
- Having provided a signed and dated Informed Consent Form
Who cannot join
- A known hypersensitivity to darunavir or to any of its excipients
- Severe hepatic impairment described as Child-Pugh class C
- Pregnancy or lactation
- Patient previously treated with darunavir that was discontinued for any reason
About this study
Official title: Post Authorization Non-interventional Study in HIV1-Infected Patients Starting or Already in Treatment With Darunavir
The purpose of this non-interventional study is a description of use of darunavir in daily practice, in retrospective and perspective manner. Darunavir will be prescribed in the usual manner and in accordance with the terms of marketing authorization. The assignment of a patient to a particular therapeutic strategy will not be decided in advance by this study protocol but instead, it will be part of the current clinical practice. The prescription of the medicinal product will be clearly separated from the decision to include the patient in the study. No additional diagnostic or monitoring procedures will be applied to the patients, and epidemiological methods will be used for the analysis of collected data. After having agreed with the patient on starting treatment with darunavir, and provided that all inclusion and exclusion criteria apply, the physician will document the patient's data. Patients will be observed for at least 48 weeks from baseline visit except for those who withdraw from the study earlier. Patients data will be collected at approximately 0, 1, 3 and 6 months after starting treatment and subsequently every 3 months in accordance with routine practice. The expected number of patients to enroll is about 900. The patients will be treated with darunavir according to the Italian label. The patient must be withdrawn from the study if the treatment with darunavir has been stopped. A last evaluation must be documented when possible, and a resistance test will be collected if available for patients discontinuing for virologic failure. At the end of study visit, information on therapy given after darunavir discontinuation will be collected. For patients discontinuing for virologic failure, data will be collected until the end of the present study, and at least two consecutive measurements of viral load after starting new antiretroviral therapy will be collected, if available. All data collected must be the result of the normal medical care of the patient. The patient's baseline data will be collected within the first week before darunavir administration (at Visit 1). For patients already in treatment with darunavir, baseline and follow up data will be collected retrospectively and prospectively. Further data collection will occur approximately at 1, 3, and 6 months and subsequently about every 3 months according to routine practice, after initiating darunavir treatment.
Read the detailed description
The patient's baseline data will be collected within the first week before darunavir administration, Visit 1. For patients already in treatment with darunavir, outside the Early Access Program, baseline and follow-up data will be collected retrospectively and prospectively. For patients switched to commercial darunavir from the Early Access Program and already in treatment with darunavir, Baseline Visit data will be collected from the Early Access Program Baseline Visit. For patients already in treatment with darunavir outside the Early Access Program, baseline data will be collected retrospectively starting from the first darunavir intake. For all patients, laboratory examination results collected within 6 months before darunavir treatment starts will be considered as baseline data. For patients switched to commercial darunavir from the Early Access Program and already in treatment with darunavir, Visit 2 won't be performed. For patients starting commercial darunavir or already in treatment with commercial darunavir outside the Early Access Program, laboratory exams related to follow-up visits, Visit 2 onward, can be performed within a time window of one month before or after the corresponding visit date. Further data collection will occur approximately at 1, 3, and 6 months and subsequently about every 3 months according to routine practice, after initiating darunavir treatment. If a patient stops treatment with darunavir at any time, the end of study visit should be performed as soon as possible. Darunavir film-coated tablet, orally administered. Orange, oval-shaped tablet, debossed with 400MG or 600MG or 300MG on one side and TMC on the other side. Duration of observation minimum 48 weeks.
- Conditions
- HIV Infections
- Being tested
- darunavir/ritonavir plus background regimen
- Keywords
- HIV, darunavir, ritonavir, Prezista, naive, experienced
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
darunavir/ritonavir plus background regimenDrug
darunavir/ritonavir, oral use, in naive and experienced patients at approved dosages
| Study group | Role | What they receive |
|---|---|---|
| 001 | darunavir/ritonavir plus background regimen darunavir/ritonavir oral use in naive and experienced patients at approved dosages Receives: Drug: darunavir/ritonavir plus background regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of viral load, as an assessment of efficacy
Measured: At least 48 weeks
Secondary outcomes (5)
Immunological response, as measured by CD4 cells count
Measured: At least 48 weeks
Impact on Health-related Quality of Life after switching to a darunavir containing regimen in accordance to the approved indication
Measured: At least 48 weeks
Neuropsychological impairment at baseline and after switching to a darunavir containing regimen in accordance to the approved indication
Measured: At least 48 weeks
Assessments of non-categorized information gathered about treatment switch to and from darunavir
Measured: At least 48 weeks
Number of patients with adverse events, as a measure of safety
Measured: At least 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2011 (estimated)
- Study startJun 2009
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag S.p.A. Clinical Trial, Study director, Janssen-Cilag S.p.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01375881
- Sponsor's protocol ID
- CR017641
- Other IDs
- TMC114HIV4042
- Status last verified
- May 2013
- First submitted
- 9 Jun 2011
- Last updated
- 6 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Authorization Non-interventional Study in HIV1-Infected Patients Starting or Already in Treatment With Darunavir
- ClinicalTrials.gov ID
- NCT01375881
- Acronym / sponsor ID
- CR017641
- Conditions
- HIV Infections
- Keywords
- HIV, darunavir, ritonavir, Prezista, naive, experienced
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Janssen-Cilag S.p.A.Industry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 17 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this non-interventional study is a description of use of darunavir in daily practice, in retrospective and perspective manner. Darunavir will be prescribed in the usual manner and in accordance with the terms of marketing authorization. The assignment of a patient to a particular therapeutic strategy will not be decided in advance by this study protocol but instead, it will be part of the current clinical practice. The prescription of the medicinal product will be clearly separated from the decision to include the patient in the study. No additional diagnostic or monitoring procedures will be applied to the patients, and epidemiological methods will be used for the analysis of collected data. After having agreed with the patient on starting treatment with darunavir, and provided that all inclusion and exclusion criteria apply, the physician will document the patient's data. Patients will be observed for at least 48 weeks from baseline visit except for those who withdraw from the study earlier. Patients data will be collected at approximately 0, 1, 3 and 6 months after starting treatment and subsequently every 3 months in accordance with routine practice. The expected number of patients to enroll is about 900. The patients will be treated with darunavir according to the Italian label. The patient must be withdrawn from the study if the treatment with darunavir has been stopped. A last evaluation must be documented when possible, and a resistance test will be collected if available for patients discontinuing for virologic failure. At the end of study visit, information on therapy given after darunavir discontinuation will be collected. For patients discontinuing for virologic failure, data will be collected until the end of the present study, and at least two consecutive measurements of viral load after starting new antiretroviral therapy will be collected, if available. All data collected must be the result of the normal medical care of the patient. The patient's baseline data will be collected within the first week before darunavir administration (at Visit 1). For patients already in treatment with darunavir, baseline and follow up data will be collected retrospectively and prospectively. Further data collection will occur approximately at 1, 3, and 6 months and subsequently about every 3 months according to routine practice, after initiating darunavir treatment.
Detailed description
The patient's baseline data will be collected within the first week before darunavir administration, Visit 1. For patients already in treatment with darunavir, outside the Early Access Program, baseline and follow-up data will be collected retrospectively and prospectively. For patients switched to commercial darunavir from the Early Access Program and already in treatment with darunavir, Baseline Visit data will be collected from the Early Access Program Baseline Visit. For patients already in treatment with darunavir outside the Early Access Program, baseline data will be collected retrospectively starting from the first darunavir intake. For all patients, laboratory examination results collected within 6 months before darunavir treatment starts will be considered as baseline data. For patients switched to commercial darunavir from the Early Access Program and already in treatment with darunavir, Visit 2 won't be performed. For patients starting commercial darunavir or already in treatment with commercial darunavir outside the Early Access Program, laboratory exams related to follow-up visits, Visit 2 onward, can be performed within a time window of one month before or after the corresponding visit date. Further data collection will occur approximately at 1, 3, and 6 months and subsequently about every 3 months according to routine practice, after initiating darunavir treatment. If a patient stops treatment with darunavir at any time, the end of study visit should be performed as soon as possible. Darunavir film-coated tablet, orally administered. Orange, oval-shaped tablet, debossed with 400MG or 600MG or 300MG on one side and TMC on the other side. Duration of observation minimum 48 weeks.
Study design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 001 | – | Drug: darunavir/ritonavir plus background regimendarunavir/ritonavir plus background regimen darunavir/ritonavir oral use in naive and experienced patients at approved dosages |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient using darunavir and ritonavir in clinical practice according to label in Italy. Both naive and experienced patients are allowed to enter the study
Key inclusion criteria (2 listed)
- Eligible for inclusion in this non-interventional study are adult patients in need of treatment with darunavir according to Italian label or already in treatment
- Having provided a signed and dated Informed Consent Form
Key exclusion criteria (4 listed)
- A known hypersensitivity to darunavir or to any of its excipients
- Severe hepatic impairment described as Child-Pugh class C
- Pregnancy or lactation
- Patient previously treated with darunavir that was discontinued for any reason
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 |
|---|---|---|
| darunavir/ritonavir plus background regimendarunavir/ritonavir, oral use, in naive and experienced patients at approved dosages | Drug | 001 |
Primary outcome
Measurement of viral load, as an assessment of efficacy
Time frame: At least 48 weeks
5 secondary outcomes
Immunological response, as measured by CD4 cells count
Time frame: At least 48 weeks
Impact on Health-related Quality of Life after switching to a darunavir containing regimen in accordance to the approved indication
Time frame: At least 48 weeks
Neuropsychological impairment at baseline and after switching to a darunavir containing regimen in accordance to the approved indication
Time frame: At least 48 weeks
Assessments of non-categorized information gathered about treatment switch to and from darunavir
Time frame: At least 48 weeks
Number of patients with adverse events, as a measure of safety
Time frame: At least 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2013.
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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.
Janssen-Cilag S.p.A. Clinical Trial study director
Janssen-Cilag S.p.A.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by Janssen-Cilag S.p.A..
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 2 inclusion and 4 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 6 May 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measurement of viral load, as an assessment of efficacy (time frame: At least 48 weeks). 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 6 May 2013.