Fuzeon (Enfuvirtide) Early Access Program for Patients With HIV-1 Infection
Status:
Completed
Trial end date:
2003-11-01
Target enrollment:
Participant gender:
Summary
This study will determine the safety and tolerability of Fuzeon (enfuvirtide) used together
with other treatments for HIV infection in patients with advanced HIV disease. Fuzeon is an
antiretroviral drug. Unlike other antiretrovirals, however, which work against the virus once
it is already in the cell, Fuzeon prevents the virus from getting into healthy cells.
Patients 18 years of age and older with advanced HIV-1 infection, who do not respond to
approved antiretroviral therapy, may be eligible for this study. Candidates must have a CD4
lymphocyte count less than 100 cells/mm3 and a viral load greater than 10,000 copies/mL. They
will be screened with a medical history, physical examination, and blood tests, and may also
have an electrocardiogram (ECG), chest x-ray and urine test.
Patients enrolled in the study will be re-examined and have additional blood tests before
beginning treatment with Fuzeon. They will then be taught how to self-inject the medicine
under the skin and will take two doses daily (less than 1/4 teaspoon each), 12 hours apart.
After the first treatment, participants will have follow-up visits at weeks 1, 2, 4, 8, 12,
24, 36, 48, and every 12 weeks after that, if necessary, until 12 weeks after the drug
becomes commercially available. Visits may be scheduled more often if a problem arises.
During the follow-up visits, patients will have blood drawn, and their blood pressure, pulse
rate and temperature will be checked. They will also report any drug side effects they have
experienced.
Patients may continue to take Fuzeon as long as they benefit from therapy and do not
experience severe side effects from the treatment. The drug will be provided to participants
until 12 weeks after it is sold in the United States.
Phase:
Phase 3
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)