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:
Boehringer Ingelheim Pharmaceuticals
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00976950
First received: September 14, 2009
Last updated: January 31, 2013
Last verified: January 2013
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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 |
|---|
|
HIV Infections |
| 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:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
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: | 51 |
| 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 |
|---|
| Patients with HIV-1 infection |
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:
- 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.
- 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
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 19 | |
| Brasov, Romania | |
| Boehringer Ingelheim Investigational site 18 | |
| Brasov, Romania | |
| Boehringer Ingelheim Investigational site 4 | |
| 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 6 | |
| Bucuresti, Romania | |
| Boehringer Ingelheim Investigational site 5 | |
| Bucuresti, Romania | |
| Boehringer Ingelheim Investigational site 7 | |
| Bucuresti, Romania | |
| Boehringer Ingelheim Investigational site 8 | |
| Bucuresti, Romania | |
| Boehringer Ingelheim Investigational site 16 | |
| Constanta, Romania | |
| Boehringer Ingelheim Investigational site 12 | |
| Craiova, Romania | |
| Boehringer Ingelheim Investigational site 11 | |
| 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 Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
Additional Information:
No publications provided
| Responsible Party: | Boehringer Ingelheim Pharmaceuticals |
| 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: | January 31, 2013 |
| Health Authority: | Romania: National Medicines Agency |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Ritonavir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013