Acquired Immune Deficiency SyndromeNCT01741831
A Post Marketing Survey Study to Evaluate the Safety and Effectiveness of Prezista
An observational study of Acquired Immune Deficiency Syndrome, run by Janssen Korea, Ltd., Korea at 1 site in South Korea.
Trial summary
The purpose of this study is to assess the safety data of darunavir in a natural clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Immune Deficiency Syndrome
- Type of treatment
- Pill or oral medicine
- How many people
- 225 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2012to Oct 2016
- 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: The study population will include patients who are diagnosed with Acquired Immune Deficiency Syndrome (AIDS), and who are prescribed with darunavir for treatment of AIDS.
Who may be able to join
- Patients who are prescribed with darunavir for treatment of Acquired Immune Deficiency Syndrome (AIDS)
Who cannot join
- Known hypersensitivity to Prezista
- Prezista coadministered with medicinal products that are highly dependent on CYP3A for clearance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Regulatory Post Marketing Surveillance of Prezista 400mg Tablet
The purpose of this study is to assess the safety data of darunavir in a natural clinical practice.
Read the detailed description
This is a non-interventional (a scientific study to make a clear and easy understanding of the cause and effect relationship), prospective (in which the participants are first identified and then followed forward as time passes), consecutive survey for collecting safety and efficacy data of darunavir in treatment of Acquired Immune Deficiency Syndrome (AIDS) in a natural clinical practice.
- Conditions
- Acquired Immune Deficiency Syndrome
- Being tested
- No intervention
- Keywords
- Acquired Immune Deficiency Syndrome, AIDS, TMC114, Darunavir, Prezista
- 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.
No interventionDrug
Also called Prezista
This is an observational study. Darunavir will be administered as per the recommended doses and will be given orally for a period of 24 weeks. For treatment naive (never received treatment for AIDS) patients: Darunavir 800 mg will be adminstered along with ritonavir 100 mg once daily. For experienced patients: Darunavir 600 mg will be administered along with ritonavir 100 mg twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Darunavir | Patients having Acquired Immune Deficiency Syndrome (AIDS) will be taking darunavir as per recommended doses. Receives: Drug: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events
Measured: Up to 30 days from end of treatment
Secondary outcomes (2)
Number of patients with viral load
Measured: Screening, Week 12, Week 24
Number of patients with CD4 T-cell count
Measured: Screening, Week 12, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startJul 2012
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Immune Deficiency SyndromeStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Korea, Ltd., Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Korea, Ltd., Korea Clinical Trial, Study director, Janssen Korea, Ltd., Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01741831
- Sponsor's protocol ID
- CR100805
- Other IDs
- TMC114HIV4074, Prezista PMS, DRV-C-11-KR-001-V06
- Status last verified
- Dec 2016
- First submitted
- 3 Dec 2012
- Last updated
- 5 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulatory Post Marketing Surveillance of Prezista 400mg Tablet
- ClinicalTrials.gov ID
- NCT01741831
- Acronym / sponsor ID
- CR100805
- Conditions
- Acquired Immune Deficiency Syndrome
- Keywords
- Acquired Immune Deficiency Syndrome, AIDS, TMC114, Darunavir, Prezista
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Janssen Korea, Ltd., KoreaIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 5 Dec 2012 (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 study is to assess the safety data of darunavir in a natural clinical practice.
Detailed description
This is a non-interventional (a scientific study to make a clear and easy understanding of the cause and effect relationship), prospective (in which the participants are first identified and then followed forward as time passes), consecutive survey for collecting safety and efficacy data of darunavir in treatment of Acquired Immune Deficiency Syndrome (AIDS) in a natural clinical practice.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Darunavir | – | Drug: No interventionPatients having Acquired Immune Deficiency Syndrome (AIDS) will be taking darunavir as per recommended doses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include patients who are diagnosed with Acquired Immune Deficiency Syndrome (AIDS), and who are prescribed with darunavir for treatment of AIDS.
Key inclusion criteria (1 listed)
- Patients who are prescribed with darunavir for treatment of Acquired Immune Deficiency Syndrome (AIDS)
Key exclusion criteria (2 listed)
- Known hypersensitivity to Prezista
- Prezista coadministered with medicinal products that are highly dependent on CYP3A for clearance
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 |
|---|---|---|
| No interventionAlso: PrezistaThis is an observational study. Darunavir will be administered as per the recommended doses and will be given orally for a period of 24 weeks. For treatment naive (never received treatment for AIDS) patients: Darunavir 800 mg will be adminstered along with ritonavir 100 mg once daily. For experienced patients: Darunavir 600 mg will be administered along with ritonavir 100 mg twice daily. | Drug | Darunavir |
Primary outcome
Number of patients with adverse events
Time frame: Up to 30 days from end of treatment
2 secondary outcomes
Number of patients with viral load
Time frame: Screening, Week 12, Week 24
Number of patients with CD4 T-cell count
Time frame: Screening, Week 12, Week 24
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 5 Dec 2016.
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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 Korea, Ltd., Korea Clinical Trial study director
Janssen Korea, Ltd., Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acquired Immune Deficiency Syndrome, run by Janssen Korea, Ltd., Korea at 1 site in South Korea.
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 2 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 5 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
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?
Number of patients with adverse events (time frame: Up to 30 days from end of treatment). 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 5 Dec 2016.