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

November 1, 2016 updated by: Hoffmann-La Roche

Multicenter, Observational, Retrospective Study to Assess the Therapeutic Effectiveness of a Strategy of Induction With Enfuvirtide Within an Optimized Regimen of Antiretroviral Drugs (ARV) in Patients Infected With HIV-1 in Routine Clinical Practice

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

58

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08901

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with HIV-1 infection having received induction therapy with Fuzeon and antiretroviral drugs

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response rate: Proportion of patients with reduction of viral load to < 50 copies/ml
Time Frame: approximately 24 months
approximately 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of treatment with Fuzeon
Time Frame: approximately 24 months
approximately 24 months
Time to undetectability, defined as time from initiation of treatment to first observation of viral load < 50 copies/ml
Time Frame: approximately 24 months
approximately 24 months
Safety: Incidence of adverse events
Time Frame: approximately 24 months
approximately 24 months
Treatment regimen: Antiretroviral drugs used
Time Frame: approximately 24 months
approximately 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

July 16, 2013

First Submitted That Met QC Criteria

July 16, 2013

First Posted (Estimate)

July 18, 2013

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML25313

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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