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NCT01902615 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01902615
Other study ID # ML25313
Secondary ID
Status Completed
Phase N/A
First received July 16, 2013
Last updated November 1, 2016
Start date January 2001
Est. completion date March 2008

Study information
Verified date November 2016
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority Spain: Ministry of Health
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 58
Est. completion date March 2008
Est. primary completion date March 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Response rate: Proportion of patients with reduction of viral load to < 50 copies/ml approximately 24 months No
Secondary Duration of treatment with Fuzeon approximately 24 months No
Secondary Time to undetectability, defined as time from initiation of treatment to first observation of viral load < 50 copies/ml approximately 24 months No
Secondary Safety: Incidence of adverse events approximately 24 months No
Secondary Treatment regimen: Antiretroviral drugs used approximately 24 months No
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