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.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01902615
First received: July 16, 2013
Last updated: August 4, 2014
Last verified: August 2014

July 16, 2013
August 4, 2014
January 2001
March 2008   (final data collection date for primary outcome measure)
Response rate: Proportion of patients with reduction of viral load to < 50 copies/ml [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01902615 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
An Observational Study of Induction Therapy With Fuzeon (Enfuvirtide) in Combination With Antiretroviral Drugs in Patients With HIV-1 Infection
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 therapeut ic effectiveness of a strategy of induction with Fuzeon (enfuvirtide) within an optimized regimen of antiretroviral drugs in patients with HIV-1 infection in ro utine clinical practice.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Probability Sample

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

HIV Infections
Not Provided
Cohort
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
March 2008
March 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01902615
ML25313
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP