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This study will evaluate patient quality of life and tolerability of a HAART (highly active antiretroviral therapy) regimen containing twice-daily subcutaneous injections of Fuzeon in clinically stable, treatment-experienced patients with HIV-1 infection. All patients will use a 31-gauge thin-walled 8mm needle to administer Fuzeon. 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARV regimen | Drug | As prescribed |
| |
| enfuvirtide [Fuzeon] |
| Measure | Description | Time Frame |
|---|---|---|
| QoL (MOS-HIV)\n | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in HIV-RNA | Week 12 | |
| Change from baseline in CD4 count | Week 12 |
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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 |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | 85012 | United States | |||
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| Drug |
90mg sc bid for 12 weeks |
|
| Bakersfield |
| California |
| 93301 |
| United States |
| Berkeley | California | 94705 | United States |
| Los Angeles | California | 90022 | United States |
| Los Angeles | California | 90026 | United States |
| Los Angeles | California | 90073 | United States |
| Modesto | California | 95350 | United States |
| Oakland | California | 94609 | United States |
| Palm Springs | California | 92262 | United States |
| Rancho Mirage | California | 92270 | United States |
| San Mateo | California | 94403 | United States |
| Tarzana | California | 91356 | United States |
| Washington D.C. | District of Columbia | 20017 | United States |
| Bay Pines | Florida | 33744 | United States |
| Boynton Beach | Florida | 33426 | United States |
| Brandon | Florida | 33511 | United States |
| Daytona Beach | Florida | 32117 | United States |
| Fort Lauderdale | Florida | 33311 | United States |
| Fort Lauderdale | Florida | 33316 | United States |
| Fort Lauderdale | Florida | 33334 | United States |
| Fort Myers | Florida | 33901 | United States |
| Jacksonville | Florida | 32204 | United States |
| Jacksonville | Florida | 32206 | United States |
| Miami | Florida | 33137 | United States |
| Miami Beach | Florida | 33139 | United States |
| Miami Beach | Florida | 33140 | United States |
| North Palm Beach | Florida | 33408 | United States |
| Oakland Park | Florida | 33334 | United States |
| Orlando | Florida | 32806 | United States |
| Plantation | Florida | 33317 | United States |
| Pompano Beach | Florida | 33062 | United States |
| Port Saint Lucie | Florida | 34952 | United States |
| Sarasota | Florida | 34239 | United States |
| South Miami | Florida | 33143 | United States |
| Tallahassee | Florida | 32308 | United States |
| Tamarac | Florida | 33321 | United States |
| Tampa | Florida | 33607 | United States |
| Tampa | Florida | 33614 | United States |
| Vero Beach | Florida | 32960 | United States |
| Atlanta | Georgia | 30308 | United States |
| Atlanta | Georgia | 30309 | United States |
| Atlanta | Georgia | 30312 | United States |
| Atlanta | Georgia | 30318 | United States |
| Atlanta | Georgia | 30327 | United States |
| Atlanta | Georgia | 30342 | United States |
| Decatur | Georgia | 30033 | United States |
| Lawrenceville | Georgia | 30045 | United States |
| Boise | Idaho | 83704 | United States |
| Chicago | Illinois | 60612 | United States |
| Springfield | Illinois | 62703 | United States |
| Topeka | Kansas | 66606 | United States |
| Wichita | Kansas | 67214 | United States |
| Louisville | Kentucky | 40202 | United States |
| Silver Spring | Maryland | 20910 | United States |
| Berkley | Michigan | 48072-1550 | United States |
| Ypsilanti | Michigan | 48197 | United States |
| Minneapolis | Minnesota | 55404 | United States |
| Kansas City | Missouri | 64111 | United States |
| Kansas City | Missouri | 64112 | United States |
| St Louis | Missouri | 63108 | United States |
| St Louis | Missouri | 63117 | United States |
| St Louis | Missouri | 63139 | United States |
| Butte | Montana | 59701 | United States |
| Las Vegas | Nevada | 89102 | United States |
| East Orange | New Jersey | 07018 | United States |
| Englewood | New Jersey | 07631 | United States |
| Jersey City | New Jersey | 07302 | United States |
| Newark | New Jersey | 07102 | United States |
| Newark | New Jersey | 07103 | United States |
| Newark | New Jersey | 07112 | United States |
| Perth Amboy | New Jersey | 08861 | United States |
| Somers Point | New Jersey | 08244 | United States |
| West Orange | New Jersey | 07052 | United States |
| Manhasset | New York | 11030 | United States |
| Mount Vernon | New York | 10550 | United States |
| New York | New York | 10011 | United States |
| New York | New York | 10016 | United States |
| Rochester | New York | 14604 | United States |
| Staten Island | New York | 10304 | United States |
| Stony Brook | New York | 11794-8153 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Akron | Ohio | 44304 | United States |
| Cincinnati | Ohio | 45206 | United States |
| Portland | Oregon | 97209-2534 | United States |
| Harrisburg | Pennsylvania | 17110 | United States |
| Philadelphia | Pennsylvania | 19107 | United States |
| Reading | Pennsylvania | 19601 | United States |
| West Reading | Pennsylvania | 19611 | United States |
| Charleston | South Carolina | 29425 | United States |
| Columbia | South Carolina | 29203 | United States |
| Austin | Texas | 78705 | United States |
| Dallas | Texas | 75219 | United States |
| Dallas | Texas | 75246 | United States |
| Fort Worth | Texas | 76104 | United States |
| Galveston | Texas | 77555 | United States |
| Houston | Texas | 77004 | United States |
| Houston | Texas | 77027 | United States |
| Houston | Texas | 77098 | United States |
| San Antonio | Texas | 78212 | United States |
| Fairfax | Virginia | 22030 | United States |
| Hampton | Virginia | 23666 | United States |
| Seattle | Washington | 98104 | United States |
| Seattle | Washington | 98109 | United States |
| Cagaus | 00725 | Puerto Rico |
| Ponce | 00717-1563 | Puerto Rico |
| San Juan | 00908 | 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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