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

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ClinicalTrials.gov Identifier: NCT01902615
Recruitment Status : Completed
First Posted : July 18, 2013
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease
HIV Infections

Study Design

Study Type : Observational
Actual Enrollment : 58 participants
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
Study Start Date : January 2001
Primary Completion Date : March 2008
Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Enfuvirtide
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Cohort


Outcome Measures

Primary Outcome Measures :
  1. Response rate: Proportion of patients with reduction of viral load to < 50 copies/ml [ Time Frame: approximately 24 months ]

Secondary Outcome Measures :
  1. Duration of treatment with Fuzeon [ Time Frame: approximately 24 months ]
  2. Time to undetectability, defined as time from initiation of treatment to first observation of viral load < 50 copies/ml [ Time Frame: approximately 24 months ]
  3. Safety: Incidence of adverse events [ Time Frame: approximately 24 months ]
  4. Treatment regimen: Antiretroviral drugs used [ Time Frame: approximately 24 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with HIV-1 infection having received induction therapy with Fuzeon and antiretroviral drugs
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01902615


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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01902615     History of Changes
Other Study ID Numbers: ML25313
First Posted: July 18, 2013    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
HIV Infections
Infection
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Enfuvirtide
HIV Fusion Inhibitors
Viral Fusion Protein Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents