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Surveillance Cohort Long-Term Toxicity Antiretrovirals in HIV-Infected Patients Enrolled in TPV Cohort

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ClinicalTrials.gov Identifier: NCT00805857
Recruitment Status : Withdrawn
First Posted : December 10, 2008
Last Update Posted : December 10, 2008
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment
HIV Infections Drug: Tipranavir

Study Type : Observational
Estimated Enrollment : 150 participants
Official Title: SCOLTA: SURVEILLANCE COHORT LONG-TERM TOXICITY ANTIRETROVIRALS
Study Start Date : June 2008
Estimated Primary Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Tipranavir
U.S. FDA Resources




Primary Outcome Measures :
  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 [ Time Frame: 48wks ]

Secondary Outcome Measures :
  1. the evaluation of tipranavir containing regimens durability, considering treatment interruption for each reason [ Time Frame: 48wks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00805857


Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00805857     History of Changes
Other Study ID Numbers: 1182.144
First Posted: December 10, 2008    Key Record Dates
Last Update Posted: December 10, 2008
Last Verified: December 2008

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Tipranavir
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents