Back to resultsSurveillance Cohort Long-term Toxicity Antiretrovirals in HIV-infected Patients Enrolled in TPV Cohort
Primary Purpose
HIV Infections
Status
Withdrawn
Phase
Locations
Study Type
Observational
Intervention
Tipranavir
Sponsored by
About this trial
This is an observational trial for HIV Infections
Eligibility Criteria
Inclusion Criteria:
- All patients > 18 years old HIV infected treated with tipranavir
Exclusion Criteria:
Sites / Locations
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
the evaluation of tipranavir containing regimens durability, considering treatment interruption for each reason
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00805857
Brief Title
Surveillance Cohort Long-term Toxicity Antiretrovirals in HIV-infected Patients Enrolled in TPV Cohort
Official Title
SCOLTA: SURVEILLANCE COHORT LONG-TERM TOXICITY ANTIRETROVIRALS
Study Type
Observational
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Withdrawn
Study Start Date
June 2008 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
Brief 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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
7. Study Design
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Tipranavir
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
the evaluation of tipranavir containing regimens durability, considering treatment interruption for each reason
Time Frame
48wks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients > 18 years old HIV infected treated with tipranavir
Exclusion Criteria:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Surveillance Cohort Long-term Toxicity Antiretrovirals in HIV-infected Patients Enrolled in TPV Cohort
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