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

Hoffmann-La Roche0 sites58 target enrollmentJanuary 2001

ConditionsHIV Infections

Overview

Phase: N/A
Intervention: Not specified
Conditions: HIV Infections
Sponsor: Hoffmann-La Roche
Enrollment: 58
Primary Endpoint: Response rate: Proportion of patients with reduction of viral load to < 50 copies/ml
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2001

End Date

March 2008

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Response rate: Proportion of patients with reduction of viral load to < 50 copies/ml

Time Frame: approximately 24 months

Secondary Outcomes

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