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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01902615

Enrollment

Registered

2013-07-18

Start date

2001-01-31

Completion date

2008-03-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Response rate: Proportion of patients with reduction of viral load to < 50 copies/ml	approximately 24 months

Secondary

Measure	Time frame
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

Countries

Spain

Outcome results