CLINICAL TRIALS PROFILE FOR FUZEON
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All Clinical Trials for FUZEON
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00050856 ↗ | Fuzeon (Enfuvirtide) Early Access Program for Patients With HIV-1 Infection | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | Phase 3 | 2002-11-01 | 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. |
| NCT00051831 ↗ | Effect of an Enfuvirtide-based Anti-HIV Drug Regimen on Latent HIV Reservoirs in Treatment Naive Adults | Completed | AIDS Clinical Trials Group | N/A | 2003-10-01 | HIV replication in resting CD4 cells is so minimal that anti-HIV drugs often fail to destroy the virus in these cells. Enfuvirtide, also known as T-20, is a type of anti-HIV drug called a fusion inhibitor. The purpose of this study is to test the ability of a T-20-enhanced treatment regimen to decrease the number of resting CD4 cells that become infected with HIV. |
| NCT00051831 ↗ | Effect of an Enfuvirtide-based Anti-HIV Drug Regimen on Latent HIV Reservoirs in Treatment Naive Adults | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | N/A | 2003-10-01 | HIV replication in resting CD4 cells is so minimal that anti-HIV drugs often fail to destroy the virus in these cells. Enfuvirtide, also known as T-20, is a type of anti-HIV drug called a fusion inhibitor. The purpose of this study is to test the ability of a T-20-enhanced treatment regimen to decrease the number of resting CD4 cells that become infected with HIV. |
| NCT00086710 ↗ | Study of Enfuvirtide in HIV-Positive Subjects | Completed | Hoffmann-La Roche | Phase 1 | 1969-12-31 | A total of 26 patients will be admitted to the clinic where they will be dosed with each injection device. There will be a 7-day washout between doses and a 7-10 day follow-up period. |
| NCT00086710 ↗ | Study of Enfuvirtide in HIV-Positive Subjects | Completed | Trimeris | Phase 1 | 1969-12-31 | A total of 26 patients will be admitted to the clinic where they will be dosed with each injection device. There will be a 7-day washout between doses and a 7-10 day follow-up period. |
| NCT00089492 ↗ | A Study Comparing the Efficacy and Safety of Once-Daily Fuzeon (Enfuvirtide) Dosing Versus the Currently Recommended Twice-Daily Dosing in Human Immunodeficiency Virus-Type 1 (HIV-1) Infected Patients | Completed | Trimeris | Phase 2 | 2004-07-01 | This study will assess the safety and efficacy of once-daily administration of Fuzeon compared with twice-daily administration in HIV-1 infected patients who have received prior treatment. Patients will also receive an optimized treatment consisting of antiretroviral (ARV) therapy as determined by the treating physician. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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