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NCT00976950 Clinical Trial

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.

HIV Infections Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00976950
Other study ID # 1182.147
Secondary ID
Status Completed
Phase N/A
First received September 14, 2009
Last updated February 24, 2014
Start date September 2009
Est. completion date July 2011

Study information
Verified date February 2014
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Romania: National Medicines Agency
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 42
Est. completion date July 2011
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Tipranavir

• ritonavir
low-dose

Locations
Country Name City State
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 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 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

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Romania, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Patients Reporting Adverse Events (AE) Any type of adverse events 48 weeks Yes
Secondary Virologic Response 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 No
Secondary Change in CD4+ Cell Count From Baseline at Week 48 48 weeks No
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