HIV InfectionsNCT00805857
Surveillance Cohort Long-term Toxicity Antiretrovirals in HIV-infected Patients Enrolled in TPV Cohort
An observational study of HIV Infections, run by Boehringer Ingelheim.
Trial summary
The SCOLTA project is a system for online surveying of adverse events to recently commercialized antiretroviral drugs and a sentinel for unexpected and late adverse events reactions arising during any antiretroviral treatment.Aim of the proposed study is: 1. 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?
- Tipranavir
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to Dec 2009
- 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
Who may be able to join
- All patients > 18 years old HIV infected treated with tipranavir
Who cannot join
None listed.
About this study
Official title: SCOLTA: SURVEILLANCE COHORT LONG-TERM TOXICITY ANTIRETROVIRALS
The SCOLTA project is a system for online surveying of adverse events to recently commercialized antiretroviral drugs and a sentinel for unexpected and late adverse events reactions arising during any antiretroviral treatment.Aim of the proposed study is:
- to evaluate the prevalence and incidence of serious adverse events and serious unexpected adverse events in HIV-infected patients enrolled in the SCOLTA project Tipranavir cohort and to identify possible risk factors
- the evaluation of tipranavir containing regimens durability, considering treatment interruption for each reason.
- Conditions
- HIV Infections
- Being tested
- Tipranavir
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TipranavirDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the prevalence and incidence of serious adverse events and serious unexpected adverse events in HIV infected patients enrolled in Tipranavir cohort and to identify possible risk factors
Measured: 48wks
Secondary outcomes (1)
the evaluation of tipranavir containing regimens durability, considering treatment interruption for each reason
Measured: 48wks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2008 (estimated)
- Study startJun 2008
- Primary completionDec 2009 (estimated)
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.
- More trials run by Boehringer IngelheimThe 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
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00805857
- Sponsor's protocol ID
- 1182.144
- Status last verified
- Aug 2018
- First submitted
- 10 Jun 2008
- Last updated
- 31 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCOLTA: SURVEILLANCE COHORT LONG-TERM TOXICITY ANTIRETROVIRALS
- ClinicalTrials.gov ID
- NCT00805857
- Acronym / sponsor ID
- 1182.144
- Conditions
- HIV Infections
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Dec 2009 (estimated)
- First posted
- 10 Dec 2008 (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 SCOLTA project is a system for online surveying of adverse events to recently commercialized antiretroviral drugs and a sentinel for unexpected and late adverse events reactions arising during any antiretroviral treatment.Aim of the proposed study is:
- to evaluate the prevalence and incidence of serious adverse events and serious unexpected adverse events in HIV-infected patients enrolled in the SCOLTA project Tipranavir cohort and to identify possible risk factors
- the evaluation of tipranavir containing regimens durability, considering treatment interruption for each reason.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients > 18 years old HIV infected treated with tipranavir
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Tipranavir | Drug | – |
Primary outcome
To evaluate the prevalence and incidence of serious adverse events and serious unexpected adverse events in HIV infected patients enrolled in Tipranavir cohort and to identify possible risk factors
Time frame: 48wks
1 secondary outcome
the evaluation of tipranavir containing regimens durability, considering treatment interruption for each reason
Time frame: 48wks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
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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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by Boehringer Ingelheim.
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 0 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: withdrawn, as of the sponsor's last update on 31 Aug 2018. 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 was withdrawn before enrolling participants, so there are no results.
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?
To evaluate the prevalence and incidence of serious adverse events and serious unexpected adverse events in HIV infected patients enrolled in Tipranavir cohort and to identify possible risk factors (time frame: 48wks). 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 31 Aug 2018.