Response rate: Proportion of patients with reduction of viral load to < 50 copies/ml
Time frame · approximately 24 months
An Observational Study of Induction Therapy With Fuzeon (Enfuvirtide) in Combination With Antiretroviral Drugs in Patients With HIV-1 Infection
Status
Completed
Phase
Not applicable
Enrollment
58
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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
Treatment arms and agents.
No intervention details reported.
Timeline
From registration to results.
First posted
Jul 18, 2013
Study start
Jan 2001
Primary completion
Mar 2008
Study completion
Mar 2008
Results posted
Not reported
Registry updated
Nov 2, 2016
Outcomes
What the study measures.
Primary outcomes
Secondary outcomes
Duration of treatment with Fuzeon
Time frame · approximately 24 months
Time to undetectability, defined as time from initiation of treatment to first observation of viral load < 50 copies/ml
Time frame · approximately 24 months
Safety: Incidence of adverse events
Time frame · approximately 24 months
Treatment regimen: Antiretroviral drugs used
Time frame · approximately 24 months
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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 locations
1 registered sites.
Spain. Showing up to 24 locations stored in the fast local snapshot.
Facility not named
Barcelona, Barcelona, Spain
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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