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| Name | Class |
|---|---|
| Trimeris | INDUSTRY |
The purpose of this study is to evaluate the tolerability of a subcutaneous needle-free injection device used to administer Fuzeon, compared with the standard needle/syringe supplied with commercial Fuzeon. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enfuvirtide [Fuzeon] | Drug | 90mg sc bid by Biojector 2000 NFID for 4 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Composite endpoint (pain, induration, nodules/cysts). | Throughout study |
| Measure | Description | Time Frame |
|---|---|---|
| Steady state C trough | Weekly | |
| Signs and symptoms associated with Fuzeon injections | 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 |
|---|---|---|---|---|---|---|
| Long Beach | California | 90813 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18771056 | Derived | Gottlieb M, Thommes JA; WAND Study Team. Short communication safety, tolerability and pharmacokinetics of enfuvirtide administered by a needle-free injection system compared with subcutaneous injection. Antivir Ther. 2008;13(5):723-7. |
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| enfuvirtide [Fuzeon] |
| Drug |
90mg sc bid by 27G1/2" needle/syringe for 4 weeks |
|
| Los Angeles |
| California |
| 90022 |
| United States |
| Los Angeles | California | 90036 | United States |
| Los Angeles | California | 90210 | United States |
| Washington D.C. | District of Columbia | 20009 | United States |
| Fort Lauderdale | Florida | 33334 | United States |
| South Miami | Florida | 33143 | United States |
| Atlanta | Georgia | 30309 | United States |
| Chicago | Illinois | 60612 | United States |
| Chicago | Illinois | 60657 | United States |
| Boston | Massachusetts | 02215-3318 | United States |
| Detroit | Michigan | 48201 | United States |
| St Louis | Missouri | 63139 | United States |
| Winston-Salem | North Carolina | 27157-1082 | United States |
| Dallas | Texas | 75246 | United States |
| Houston | Texas | 77004 | United States |
| Annandale | Virginia | 22003 | United States |
| 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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