An Observational Study of Induction Therapy With Fuzeon (Enfuvirtide) in Combination With Antiretroviral Drugs in Patients With HIV-1 Infection
Completed
- Conditions
- HIV Infections
- Registration Number
- NCT01902615
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
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
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Exclusion Criteria
- Patients who did not receive Fuzeon treatment
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate: Proportion of patients with reduction of viral load to < 50 copies/ml approximately 24 months
- Secondary Outcome Measures
Name Time Method Safety: Incidence of adverse events approximately 24 months Duration of treatment with Fuzeon approximately 24 months Treatment regimen: Antiretroviral drugs used 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