Clinical Trial Result Information

Protocol number
NV16471

Title of Study
Injection Site Reaction Sub-study of Fuzeon

Sponsor
Hoffmann-La Roche Inc.; Trimeris Inc.

Company division
Pharmaceutical

Product name
Fuzeon

Generic name
enfuvirtide

Therapeutic area
Treatment of HIV-1 infection

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

Phase of development
III

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.

Date of report
To be Published