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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: July 16, 2013
Last updated: May 4, 2016
Last verified: May 2016
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.

HIV Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Response rate: Proportion of patients with reduction of viral load to < 50 copies/ml [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of treatment with Fuzeon [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
  • Time to undetectability, defined as time from initiation of treatment to first observation of viral load < 50 copies/ml [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
  • Treatment regimen: Antiretroviral drugs used [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]

Enrollment: 58
Study Start Date: January 2001
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with HIV-1 infection having received induction therapy with Fuzeon and antiretroviral drugs

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01902615

Barcelona, Spain, 08901
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT01902615     History of Changes
Other Study ID Numbers: ML25313 
Study First Received: July 16, 2013
Last Updated: May 4, 2016
Health Authority: Spain: Ministry of Health

Additional relevant MeSH terms:
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
HIV Fusion Inhibitors
Molecular Mechanisms of Pharmacological Action
Viral Fusion Protein Inhibitors processed this record on May 26, 2016