An Observational Study of Induction Therapy With Fuzeon (Enfuvirtide) in Combination With Antiretroviral Drugs in Patients With HIV-1 Infection

NCT ID: NCT01902615

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

58 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-01-31

Study Completion Date

2008-03-31

Brief Summary

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This multicenter, retrospective, observational study will evaluate the therapeutic effectiveness of a strategy of induction with Fuzeon (enfuvirtide) within an optimized regimen of antiretroviral drugs in patients with HIV-1 infection in routine clinical practice.

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

RETROSPECTIVE

Study Groups

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Cohort

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Adult patients, \>/= 18 years of age
* HIV-1+ infection
* Patients with a viral load \> 50 copies/ml who have received induction treatment with Fuzeon in combination with antiretroviral treatment
* Naïve for Fuzeon at initiation of induction treatment
* Antiretroviral treatment of at least 12 months duration

Exclusion Criteria

* Patients who did not receive Fuzeon treatment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Barcelona, Barcelona, Spain

Site Status

Countries

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Spain

Other Identifiers

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ML25313

Identifier Type: -

Identifier Source: org_study_id