HIV InfectionNCT01065792
Stocrin Re-examination Study (0831-028)
An observational study of HIV Infection, run by Merck Sharp & Dohme LLC.
Trial summary
This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of STOCRIN through collecting the safety and efficacy information according to the Re-examination Regulation for New… Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- HIV Infection
- How many people
- 728 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Feb 2014
- 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 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with HIV-1 infection treated with STOCRIN
Who may be able to join
- HIV-1 Infected Patient
- Patient Who Is Treated With Stocrin 600 Mg Tablet Within Local Label During The Enrollment Period (A Patient Who Changes The Therapy From Stocrin 200 Mg Capsule To Stocrin 600 Mg Tablet Can Be Eligible.)
Who cannot join
- Patient Who Has A Contraindication To Stocrin According To The Local Label
About this study
Official title: Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of STOCRIN in Usual Practice
This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of STOCRIN through collecting the safety and efficacy information according to the Re-examination Regulation for New Drugs.
Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
- Conditions
- HIV Infection
- Keywords
- HIV Infection
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with HIV-1 infection taking Stocrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of patients with any adverse experience
Measured: Up to 14 days following cessation of treatment
Proportion of patients with HIV-1 RNA levels of less than 400 copies per milliliter after treatment
Measured: At 12 weeks +/- 2 weeks and at 24 weeks +/- 2 weeks after first treatment
Change from baseline in CD4 cell count and overall efficacy evaluation by investigator (success, failure or can not be assessed)
Measured: At 12 weeks +/- 2 weeks and at 24 weeks +/- 2 weeks after first treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2010 (estimated)
- Study startMar 2009
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- 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
- Time perspective
- Prospective
- Enrolment
- 728 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01065792
- Sponsor's protocol ID
- 0831-028
- Other IDs
- 2010_008
- Status last verified
- Jul 2015
- First submitted
- 8 Feb 2010
- Last updated
- 21 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of STOCRIN in Usual Practice
- ClinicalTrials.gov ID
- NCT01065792
- Acronym / sponsor ID
- 0831-028
- Conditions
- HIV Infection
- Keywords
- HIV Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 728 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 9 Feb 2010 (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.
This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of STOCRIN through collecting the safety and efficacy information according to the Re-examination Regulation for New Drugs.
Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with HIV-1 infection taking Stocrin |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with HIV-1 infection treated with STOCRIN
Key inclusion criteria (2 listed)
- HIV-1 Infected Patient
- Patient Who Is Treated With Stocrin 600 Mg Tablet Within Local Label During The Enrollment Period (A Patient Who Changes The Therapy From Stocrin 200 Mg Capsule To Stocrin 600 Mg Tablet Can Be Eligible.)
Key exclusion criteria (1 listed)
- Patient Who Has A Contraindication To Stocrin According To The Local Label
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percent of patients with any adverse experience
Time frame: Up to 14 days following cessation of treatment
Proportion of patients with HIV-1 RNA levels of less than 400 copies per milliliter after treatment
Time frame: At 12 weeks +/- 2 weeks and at 24 weeks +/- 2 weeks after first treatment
Change from baseline in CD4 cell count and overall efficacy evaluation by investigator (success, failure or can not be assessed)
Time frame: At 12 weeks +/- 2 weeks and at 24 weeks +/- 2 weeks after first treatment
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 21 Jul 2015.
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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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infection, run by Merck Sharp & Dohme LLC.
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 1 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 21 Jul 2015. 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?
Percent of patients with any adverse experience (time frame: Up to 14 days following cessation of treatment). The study lists 3 primary outcomes in all. 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 21 Jul 2015.