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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

September 14, 2009
February 24, 2014
September 2009
July 2011   (final data collection date for primary outcome measure)
Number of Patients Reporting Adverse Events (AE) [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Any type of adverse events
The primary objective is to evaluate the safety of a HAART regimen that includes Aptivus coadministered with low dose of ritonavir in clinical practice [ Time Frame: 48 weeks ]
Complete list of historical versions of study NCT00976950 on ClinicalTrials.gov Archive Site
  • 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 ]
Secondary endpoints are the virologic response at week 48 and change in CD4plus cell count from baseline to week 48. [ Time Frame: 48 weeks ]
Not Provided
Not Provided
 
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.
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.

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

patients

HIV Infections
  • Drug: Tipranavir
  • Drug: ritonavir
    low-dose
Patients with HIV-1 infection
Interventions:
  • Drug: Tipranavir
  • Drug: ritonavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
July 2011
July 2011   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Romania
 
NCT00976950
1182.147
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP