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.

February 24, 2014 updated by: Boehringer Ingelheim

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
      • Arad, Romania
        • Boehringer Ingelheim Investigational Site 9
      • Bacau, Romania
        • Boehringer Ingelheim Investigational Site 13
      • Brasov, Romania
        • Boehringer Ingelheim Investigational Site 17
      • Brasov, Romania
        • Boehringer Ingelheim Investigational Site 18
      • Brasov, Romania
        • Boehringer Ingelheim Investigational Site 19
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 1
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 2
      • 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 8
      • Constanta, Romania
        • Boehringer Ingelheim Investigational Site 16
      • Craiova, Romania
        • Boehringer Ingelheim Investigational Site 11
      • Craiova, Romania
        • Boehringer Ingelheim Investigational Site 12
      • Galati, Romania
        • Boehringer Ingelheim Investigational Site 15
      • Tg.Mures, Romania
        • Boehringer Ingelheim Investigational Site 20
      • Timisoara, Romania
        • Boehringer Ingelheim Investigational Site 10
      • Vaslui, Romania
        • Boehringer Ingelheim Investigational Site 14

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with HIV-1 infection
Drug: Tipranavir
Drug: ritonavir
low-dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients Reporting Adverse Events (AE)
Time Frame: 48 weeks
Any type of adverse events
48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
48 weeks
Change in CD4+ Cell Count From Baseline at Week 48
Time Frame: 48 weeks
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

September 14, 2009

First Submitted That Met QC Criteria

September 14, 2009

First Posted (Estimate)

September 15, 2009

Study Record Updates

Last Update Posted (Estimate)

March 20, 2014

Last Update Submitted That Met QC Criteria

February 24, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1182.147

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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