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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.

NCT ID: NCT00976950

Last Updated: 2014-03-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with HIV-1 infection

Tipranavir

Intervention Type DRUG

ritonavir

Intervention Type DRUG

low-dose

Interventions

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Tipranavir

Intervention Type DRUG

ritonavir

low-dose

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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Boehringer Ingelheim Investigational site 9

Arad, , Romania

Site Status

Boehringer Ingelheim Investigational site 13

Bacau, , Romania

Site Status

Boehringer Ingelheim Investigational site 17

Brasov, , Romania

Site Status

Boehringer Ingelheim Investigational site 18

Brasov, , Romania

Site Status

Boehringer Ingelheim Investigational site 19

Brasov, , Romania

Site Status

Boehringer Ingelheim Investigational site 1

Bucharest, , Romania

Site Status

Boehringer Ingelheim Investigational site 2

Bucharest, , Romania

Site Status

Boehringer Ingelheim Investigational site 3

Bucharest, , Romania

Site Status

Boehringer Ingelheim Investigational site 4

Bucharest, , Romania

Site Status

Boehringer Ingelheim Investigational site 5

Bucharest, , Romania

Site Status

Boehringer Ingelheim Investigational site 6

Bucharest, , Romania

Site Status

Boehringer Ingelheim Investigational site 7

Bucharest, , Romania

Site Status

Boehringer Ingelheim Investigational site 8

Bucharest, , Romania

Site Status

Boehringer Ingelheim Investigational site 16

Constanța, , Romania

Site Status

Boehringer Ingelheim Investigational site 11

Craiova, , Romania

Site Status

Boehringer Ingelheim Investigational site 12

Craiova, , Romania

Site Status

Boehringer Ingelheim Investigational site 15

Galati, , Romania

Site Status

Boehringer Ingelheim Investigational site 20

Tg.Mures, , Romania

Site Status

Boehringer Ingelheim Investigational site 10

Timișoara, , Romania

Site Status

Boehringer Ingelheim Investigational site 14

Vaslui, , Romania

Site Status

Countries

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Romania

Other Identifiers

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1182.147

Identifier Type: -

Identifier Source: org_study_id

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