Clinical trial NCT00976950: 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.
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2009-09-15
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients Reporting Adverse Events (AE)
timeFrame: 48 weeks
Secondary outcomes:
measure: Virologic Response
timeFrame: 48 weeks
measure: Change in CD4+ Cell Count From Baseline at Week 48
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Arad
country: Romania
facility: Boehringer Ingelheim Investigational site 9
city: Bacau
country: Romania
facility: Boehringer Ingelheim Investigational site 13
city: Brasov
country: Romania
facility: Boehringer Ingelheim Investigational site 17
city: Brasov
country: Romania
facility: Boehringer Ingelheim Investigational site 18
city: Brasov
country: Romania
facility: Boehringer Ingelheim Investigational site 19
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational site 1
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational site 2
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational site 3
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational site 4
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational site 5
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational site 6
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational site 7
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational site 8
city: Constanta
country: Romania
facility: Boehringer Ingelheim Investigational site 16
city: Craiova
country: Romania
facility: Boehringer Ingelheim Investigational site 11
city: Craiova
country: Romania
facility: Boehringer Ingelheim Investigational site 12
city: Galati
country: Romania
facility: Boehringer Ingelheim Investigational site 15
city: Tg.Mures
country: Romania
facility: Boehringer Ingelheim Investigational site 20
city: Timisoara
country: Romania
facility: Boehringer Ingelheim Investigational site 10
city: Vaslui
country: Romania
facility: Boehringer Ingelheim Investigational site 14
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: