NCT00805857

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

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2008

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 10, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

1.5 years

First QC Date

June 10, 2008

Last Update Submit

August 29, 2018

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    48wks

Interventions

TipranavirDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HIV Infections

Interventions

tipranavir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR
0

Study Design

Study Type
observational
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 10, 2008

First Posted

December 10, 2008

Study Start

June 1, 2008

Primary Completion

December 1, 2009

Last Updated

August 31, 2018

Record last verified: 2018-08