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| Name | Class |
|---|---|
| Trimeris | INDUSTRY |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optimized Background ARVs | Drug | As prescribed |
| |
| enfuvirtide [Fuzeon] |
| Measure | Description | Time Frame |
|---|---|---|
| Viral load.\n\n | Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| CD4 lymphocyte count. | Week 48 | |
| AEs, laboratory abnormalities, local injection site reactions, AIDS-defining events.\n | 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 |
|---|---|---|---|---|---|---|
| Hobson City | Alabama | 36201 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18474492 | Derived | Wright D, Rodriguez A, Godofsky E, Walmsley S, Labriola-Tompkins E, Donatacci L, Shikhman A, Tucker E, Chiu YY, Chung J, Rowell L, Demasi R, Graham N, Salgo M. Efficacy and safety of 48 weeks of enfuvirtide 180 mg once-daily dosing versus 90 mg twice-daily dosing in HIV-infected patients. HIV Clin Trials. 2008 Mar-Apr;9(2):73-82. doi: 10.1310/hct0902-73. |
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| Drug |
180mg sc once daily for 48 weeks |
|
| enfuvirtide [Fuzeon] | Drug | 90mg sc bid for 48 weeks |
|
| Fountain Valley |
| California |
| 92708 |
| United States |
| Los Angeles | California | 90022 | United States |
| Los Angeles | California | 90048 | United States |
| Denver | Colorado | 80262 | United States |
| Bradenton | Florida | 34209 | United States |
| Miami | Florida | 33136 | United States |
| North Miami Beach | Florida | 33169 | United States |
| Orlando | Florida | 32803 | United States |
| Sarasota | Florida | 34239 | United States |
| Atlanta | Georgia | 30308 | United States |
| New Orleans | Louisiana | 70112 | United States |
| Boston | Massachusetts | 02118 | United States |
| Detroit | Michigan | 48202-2689 | United States |
| Union | New Jersey | 07083 | United States |
| Albany | New York | 12208 | United States |
| Allentown | Pennsylvania | 18102-7017 | United States |
| Philadelphia | Pennsylvania | 19102 | United States |
| Philadelphia | Pennsylvania | 19107 | United States |
| Austin | Texas | 78705 | United States |
| Houston | Texas | 77030 | United States |
| Toronto | Ontario | M5G 2C4 | Canada |
| Montreal | Quebec | H2X 2P4 | Canada |
| Montreal | Quebec | H3G 1A4 | Canada |
| Ponce | 00732 | Puerto Rico |
| San Juan | 00921-3201 | Puerto Rico |
| San Juan | 00935 | 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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