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.

Completed

• Conditions: HIV Infections
• Interventions: Drug: Tipranavir; Drug: ritonavir

• Registration Number: NCT00976950
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-14
• Study First Submitted QC: 2009-09-14
• Study First Posted: 2009-09-15
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Results First Submitted: 2012-05-30
• Results First Submitted QC: 2012-07-09
• Results First Posted: 2012-08-16
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-24
• Last Update Posted: 2014-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with HIV-1 infection	Tipranavir	-
Patients with HIV-1 infection	ritonavir	-

Primary Outcome Measures

Name	Time	Method
Number of Patients Reporting Adverse Events (AE)	48 weeks	Any type of adverse events

Secondary Outcome Measures

Name	Time	Method
Virologic Response	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.
Change in CD4+ Cell Count From Baseline at Week 48	48 weeks

Trial Locations

Locations (20)

Boehringer Ingelheim Investigational site 17; 🇷🇴 Brasov, Romania

Boehringer Ingelheim Investigational site 2; 🇷🇴 Bucuresti, Romania

Boehringer Ingelheim Investigational site 20; 🇷🇴 Tg.Mures, Romania

Boehringer Ingelheim Investigational site 9; 🇷🇴 Arad, Romania

Boehringer Ingelheim Investigational site 1; 🇷🇴 Bucuresti, Romania

Boehringer Ingelheim Investigational site 7; 🇷🇴 Bucuresti, Romania

Boehringer Ingelheim Investigational site 16; 🇷🇴 Constanta, 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 15; 🇷🇴 Galati, Romania

Boehringer Ingelheim Investigational site 10; 🇷🇴 Timisoara, Romania

Boehringer Ingelheim Investigational site 13; 🇷🇴 Bacau, Romania

Boehringer Ingelheim Investigational site 19; 🇷🇴 Brasov, Romania

Boehringer Ingelheim Investigational site 18; 🇷🇴 Brasov, Romania

Boehringer Ingelheim Investigational site 3; 🇷🇴 Bucuresti, Romania

Boehringer Ingelheim Investigational site 8; 🇷🇴 Bucuresti, Romania

Boehringer Ingelheim Investigational site 11; 🇷🇴 Craiova, Romania

Boehringer Ingelheim Investigational site 12; 🇷🇴 Craiova, Romania

Boehringer Ingelheim Investigational site 14; 🇷🇴 Vaslui, Romania