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| Name | Class |
|---|---|
| Trimeris | INDUSTRY |
This study will evaluate the signs and symptoms associated with Fuzeon injection (90mg sc) using the B2000 needle-free injection device, in HIV-1 positive patients experienced to Fuzeon treatment, but having difficulty tolerating long-term (>4 weeks) administration of Fuzeon with the standard needle and syringe. Patients will be randomized to the B2000 device or the standard needle and syringe for 4 weeks; all patients will use the B2000 device for the next 4 weeks. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enfuvirtide [Fuzeon] | Drug | 90mg sc bid by Biojector 2000 NFID for 8 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Composite endpoint (pain, induration, nodules/cysts) | Throughout study |
| Measure | Description | Time Frame |
|---|---|---|
| AEs and ISRs | Throughout study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35294-2050 | United States | |||
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| enfuvirtide [Fuzeon] |
| Drug |
90mg sc bid by standard needle and syringe for 4 weeks, followed by 90mg sc bid by Biojector 2000 NFID for 4 weeks. |
|
| Phoenix |
| Arizona |
| 85006 |
| United States |
| Phoenix | Arizona | 85012 | United States |
| Fountain Valley | California | 92708 | United States |
| Hayward | California | 94545 | United States |
| Long Beach | California | 90813 | United States |
| Los Angeles | California | 90036 | United States |
| Palm Springs | California | 92262 | United States |
| San Francisco | California | 94115 | United States |
| Santa Clara | California | 95051 | United States |
| Denver | Colorado | 80220 | United States |
| Fort Lauderdale | Florida | 33316 | United States |
| Fort Myers | Florida | 33901 | United States |
| North Miami Beach | Florida | 33169 | United States |
| Orlando | Florida | 32803 | United States |
| Plantation | Florida | 33317 | United States |
| Port Saint Lucie | Florida | 34952 | United States |
| Tampa | Florida | 33614 | United States |
| Atlanta | Georgia | 30318 | United States |
| Decatur | Georgia | 30033 | United States |
| Boise | Idaho | 83704 | United States |
| Chicago | Illinois | 60657 | United States |
| Baltimore | Maryland | 21201 | United States |
| Silver Spring | Maryland | 20910 | United States |
| Boston | Massachusetts | 02215-3318 | United States |
| Berkley | Michigan | 48072-1550 | United States |
| St Louis | Missouri | 63117 | United States |
| St Louis | Missouri | 63139 | United States |
| Somers Point | New Jersey | 08244 | United States |
| Voorhees Township | New Jersey | 08043 | United States |
| New York | New York | 10011 | United States |
| New York | New York | 10016 | United States |
| Rochester | New York | 14604 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Portland | Oregon | 97209-2534 | United States |
| Philadelphia | Pennsylvania | 19107 | United States |
| Fort Worth | Texas | 76104 | United States |
| Galveston | Texas | 77555 | United States |
| Houston | Texas | 77027 | United States |
| Houston | Texas | 77098 | United States |
| Hampton | Virginia | 23666 | United States |
| Spokane | Washington | 99204 | United States |
| Ponce | 00717-1563 | Puerto Rico |
| Santurce | 00909 | Puerto Rico |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000077560 | Enfuvirtide |
| ID | Term |
|---|---|
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D015700 | HIV Envelope Protein gp41 |
| D014760 | Viral Fusion Proteins |
| D050576 | Membrane Fusion Proteins |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D015488 | HIV Antigens |
| D000956 | Antigens, Viral |
| D014764 | Viral Proteins |
| D054299 | env Gene Products, Human Immunodeficiency Virus |
| D015686 | Gene Products, env |
| D012191 | Retroviridae Proteins |
| D054298 | Human Immunodeficiency Virus Proteins |
| D014759 | Viral Envelope Proteins |
| D015678 | Viral Structural Proteins |
| D000941 | Antigens |
| D001685 | Biological Factors |
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