- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00805857
Surveillance Cohort Long-term Toxicity Antiretrovirals in HIV-infected Patients Enrolled in TPV Cohort
August 29, 2018 updated by: Boehringer Ingelheim
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.
Study Overview
Study Type
Observational
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All patients > 18 years old HIV infected treated with tipranavir
Exclusion Criteria:
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
48wks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the evaluation of tipranavir containing regimens durability, considering treatment interruption for each reason
Time Frame: 48wks
|
48wks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Anticipated)
December 1, 2009
Study Registration Dates
First Submitted
June 10, 2008
First Submitted That Met QC Criteria
December 9, 2008
First Posted (Estimate)
December 10, 2008
Study Record Updates
Last Update Posted (Actual)
August 31, 2018
Last Update Submitted That Met QC Criteria
August 29, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Anti-Infective Agents
- Antiviral Agents
- Anti-HIV Agents
- Anti-Retroviral Agents
- Tipranavir
Other Study ID Numbers
- 1182.144
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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