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A Post Marketing Surveillance Study Assessing the Long-term Efficacy and Safety of Aptivus Co-administered With Low-dose Ritonavir in Treatment Experienced Patients With HIV-1 Infection in the Daily Clinical Practice.

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ClinicalTrials.gov Identifier: NCT00976950
Recruitment Status : Completed
First Posted : September 15, 2009
Results First Posted : August 16, 2012
Last Update Posted : March 20, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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Brief Summary:
The aim of this trial is to evaluate the safety and virological and immunological efficacy of Aptivus in treatment-experienced patients with advanced HIV-1 infection who had developed resistance to more than one protease inhibitor.

Condition or disease Intervention/treatment
HIV Infections Drug: Tipranavir Drug: ritonavir

Study Design
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Study Type : Observational
Actual Enrollment : 42 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Post Marketing Surveillance Study Assessing the Long-term Efficacy and Safety of Tipranavir (Aptivus®) Co-administered With Low-dose Ritonavir in Treatment Experienced Patients With HIV-1 Infection in the Daily Clinical Practice.
Study Start Date : September 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients with HIV-1 infection Drug: Tipranavir
Drug: ritonavir
low-dose


Outcome Measures
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Primary Outcome Measures :
  1. Number of Patients Reporting Adverse Events (AE) [ Time Frame: 48 weeks ]
    Any type of adverse events


Secondary Outcome Measures :
  1. Virologic Response [ Time Frame: 48 weeks ]
    Virologic response is defined as HIV viral load of < 50 copies/mL before week 48 and without subsequent rebound or change of ARV therapy prior to week 48. A rebound is defined by two consecutive measurements of VL >= 50 copies/ml, at least two weeks apart, after two consecutive measurements of VL< 50 copies/ml. Because of many missing data concerning the viral load, the virologic response could be determined only for four patients.

  2. Change in CD4+ Cell Count From Baseline at Week 48 [ Time Frame: 48 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients
Criteria

Inclusion criteria:

  1. HIV-1 infected patients who are treatment experienced and infected with HIV-1 strains resistant to more than one protease inhibitor and no other therapeutic options.
  2. The inclusion criteria follow the same criteria which are describe in the newest SPC

Exclusion criteria:

The exclusion criteria follow the same criteria which are describe in the newest SPC

Contacts and Locations
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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): NCT00976950


Locations
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Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Additional Information:

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00976950    
Other Study ID Numbers: 1182.147
First Posted: September 15, 2009    Key Record Dates
Results First Posted: August 16, 2012
Last Update Posted: March 20, 2014
Last Verified: February 2014
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Disease Attributes
Pathologic Processes
Ritonavir
Tipranavir
HIV Protease Inhibitors
Viral Protease Inhibitors
Protease Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors