Clinical Trial Result Information
Protocol number
MV16721
Title of Study
Multicenter open-label early access program of Enfuvirtide (T-20, HIV-1 Fusion Inhibitor) in combination with free choice antiviral regimen in patients with advanced HIV-infection.
Sponsor
F. Hoffmann-La Roche Ltd.
Company division
Pharmaceutical
Product name
Fuzeon
Generic name
enfuvirtide
Therapeutic area
HIV Infections
Clinical study summary
This was a multicenter, open-label, single arm study in patients with advanced HIV disease, to assess the safety and tolerability of Fuzeon (enfuvirtide) in combination with a free choice antiviral regimen.
Study center(s)
112 centers in Austria, Belgium, Denmark, Germany, Greece, Italy, Netherlands and Switzerland.
Phase of development
IV
Objectives
The objective of the study was to assess safety and tolerability of Fuzeon in patients with advanced HIV disease who are unable to construct a viable regimen from among approved antiretroviral (ARV) agents.
Methodology
Eligible patients were treated with Fuzeon 90mg sc twice daily, and were encouraged to start a new background antiretroviral regimen simultaneously with starting Fuzeon treatment. Patients were seen at 2, 4, 8 and 12 weeks after baseline, and subsequently after every 12 weeks. Details of serious AIDS-defining events (ADEs) and serious adverse events (SAEs) were recorded at each visit.
Number of patients (planned/analyzed)
Planned: 650. Enrolled: 450.
Diagnosis and main criteria for inclusion
Patients were HIV-1 infected adults or adolescents (≥16 years of age) with a CD4 lymphocyte count ≤100 cells/mm3 and HIV-1 RNA viral load ≥10,000 copies/mL while on highly active antiretroviral therapy (HAART). Patients had prior documented genotypic or phenotypic resistance, treatment-limited toxicity, and/or at least 6 months' prior experience with each of the three currently available classes of ARVs.
Test product, dose and mode of administration or test procedure
Fuzeon (enfuvirtide) at a dose of 90mg self-administered twice daily as subcutaneous injections.
Duration of treatment
Median exposure to Fuzeon was 21 weeks (range 0.3 - 72.4 weeks)
Reference therapy, dose and mode of administration or reference procedure
N/A
Criteria for evaluation (efficacy, safety)
Safety and tolerability parameters were assessed.
Safety: SAEs; adverse events leading to discontinuation of Fuzeon; serious ADEs.
Statistical methods
Summary descriptive statistics included the number, mean, median, standard deviation (SD), minimum, and maximum for continuous variables and number and percent for categorical variables.
Summary (efficacy, safety, other results)
Safety: A total of 430 patients were included in the safety analysis. Twenty-one (4.9%) patients died during the study. Cerebral toxoplasmosis and HIV infection each led to the death of 2 patients. No other reported event caused the death of more than one patient. Eighty-five (19.8%) patients reported 133 adverse events that met the protocol definition for seriousness or led to discontinuation of Fuzeon.
The most common SAEs reported were pyrexia, pneumonia and anemia, occurring in 9, 5 and 5 patients, respectively. Only 13 patients experienced SAEs that were considered to be related to the study drug. The most frequently reported related SAE was pyrexia (4 patients).
Adverse events resulting in discontinuation were reported for 52 patients (12.1%). The most frequently reported single adverse event leading to discontinuation was injection site reaction, (7 patients). In total, 12 patients experienced adverse events leading to discontinuation that were associated with the injection site (injection site reaction, injection site pain, injection site swelling and injection site nodule).
The most frequently reported serious ADEs were cytomegalovirus (5 patients), toxoplasmosis (3 patients), herpes zoster (2 patients) and candidiasis (2 patients).
Conclusions
Results of the study are consistent with previous safety findings indicating that Fuzeon was well tolerated, and there was no evidence of exacerbation of any known toxicities associated with oral ARV therapy in this group of treatment-experienced patients.
Date of report
1/1/2007
Click here for the protocol registry listing of this trial.
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