Surveillance Cohort Long-term Toxicity Antiretrovirals in HIV-infected Patients Enrolled in TPV Cohort

Withdrawn

• Conditions: HIV Infections

• Registration Number: NCT00805857
• Lead Sponsor: Boehringer Ingelheim

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:

1. 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

2. the evaluation of tipranavir containing regimens durability, considering treatment interruption for each reason.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-10
• Study First Submitted QC: 2008-12-09
• Study First Posted: 2008-12-10
• Primary Completion: 2009-12
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-29
• Last Update Posted: 2018-08-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• All patients > 18 years old HIV infected treated with tipranavir

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	48wks

Secondary Outcome Measures

Name	Time	Method
the evaluation of tipranavir containing regimens durability, considering treatment interruption for each reason	48wks