Clinical Trial Result Information

Title of Study:
Injection Site Reaction Sub-study of Fuzeon

Fast Facts:

Protocol number:	NV16471
Sponsor:	Hoffmann-La Roche Inc.; Trimeris Inc.
Company division:	Pharmaceutical
Product name:	Fuzeon
Generic name:	enfuvirtide
Phase of development:	III
Therapeutic area, approved indication:	Treatment of HIV-1 infection
Date of report:	To be Published

Clinical study summary:
This was an open-label, non-comparative, multiple-dose study to assess injection site reactions (ISRs) following treatment with enfuvirtide (Fuzeon) 90 mg administered twice daily (bid) by the subcutaneous (sc) route.

Study center(s) :
3 centers in the United States

Objectives:
To evaluate injection site reaction pathology in various stages of evolution following treatment with Fuzeon 90 mg administered sc bid.

Methodology:
Patients were categorised as having 1) no obvious ISR, 2) ISR but no evidence of nodule formation or 3) ISR including nodule formation. An excisional biopsy specimen of at least 1cm3 of tissue volume was taken, and subjected to histopathological examination.

Number of patients (planned/analyzed):
7

Diagnosis and main criteria for inclusion:
Human Immunodeficiency Virus Type-1 (HIV-1) infected males or females ( >= 16 years of age) who were participating in ongoing Fuzeon phase II and phase III clinical trials; willing to undergo an excisional biopsy of injection site reactions

Test product, dose and mode of administration or test procedure:
Fuzeon, 90 mg/sc/bid

Duration of treatment:
12 weeks

Reference therapy, dose and mode of administration or reference procedure:
Not applicable

Criteria for evaluation (efficacy, safety):
Histopathology of biopsy specimen

Statistical methods:
Not applicable

Summary (efficacy, safety, other results):
No official clinical study report is available at this time for this trial, and, as a result, trial result information is not captured in this results database. However, results on this trial were reported in a publication that is referenced in the “Publications” field below.

Conclusions:
Not applicable

Publications (references, if available):
Ball RA, Kinchelow T, et al. Injection site reactions (ISRs) with the HIV infusion inhibitor enfuvirtide (T-20). J Am Acad Dermatol. 2003 Nov;49(5):826-831.