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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.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00976950
First received: September 14, 2009
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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 Intervention
HIV Infections
Drug: Tipranavir
Drug: ritonavir

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Number of Patients Reporting Adverse Events (AE) [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    Any type of adverse events


Secondary Outcome Measures:
  • Virologic Response [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    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.

  • Change in CD4+ Cell Count From Baseline at Week 48 [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: September 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with HIV-1 infection Drug: Tipranavir Drug: ritonavir
low-dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00976950

Locations
Romania
Boehringer Ingelheim Investigational site 9
Arad, Romania
Boehringer Ingelheim Investigational site 13
Bacau, Romania
Boehringer Ingelheim Investigational site 17
Brasov, Romania
Boehringer Ingelheim Investigational site 18
Brasov, Romania
Boehringer Ingelheim Investigational site 19
Brasov, Romania
Boehringer Ingelheim Investigational site 8
Bucuresti, Romania
Boehringer Ingelheim Investigational site 1
Bucuresti, Romania
Boehringer Ingelheim Investigational site 3
Bucuresti, Romania
Boehringer Ingelheim Investigational site 4
Bucuresti, Romania
Boehringer Ingelheim Investigational site 5
Bucuresti, Romania
Boehringer Ingelheim Investigational site 6
Bucuresti, Romania
Boehringer Ingelheim Investigational site 7
Bucuresti, Romania
Boehringer Ingelheim Investigational site 2
Bucuresti, Romania
Boehringer Ingelheim Investigational site 16
Constanta, Romania
Boehringer Ingelheim Investigational site 11
Craiova, Romania
Boehringer Ingelheim Investigational site 12
Craiova, Romania
Boehringer Ingelheim Investigational site 15
Galati, Romania
Boehringer Ingelheim Investigational site 20
Tg.Mures, Romania
Boehringer Ingelheim Investigational site 10
Timisoara, Romania
Boehringer Ingelheim Investigational site 14
Vaslui, Romania
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00976950     History of Changes
Other Study ID Numbers: 1182.147
Study First Received: September 14, 2009
Results First Received: May 30, 2012
Last Updated: February 24, 2014
Health Authority: Romania: National Medicines Agency

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Communicable Diseases
HIV Infections
Infection
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Ritonavir
Tipranavir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014