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This study will evaluate the safety and tolerability of subcutaneous Fuzeon in patients with advanced HIV-1 infection unable to construct an appropriate treatment regimen from currently available antiretroviral agents. The anticipated time on study treatment is 3-12 months, and the target sample size is 9 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enfuvirtide | Experimental | Participants will receive 180 milligrams (mg) of enfuvirtide adminstered twice daily as subcutaneous injections |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enfuvirtide | Drug | Participants will receive a total daily dose of 180mg of enfurtide administered twice daily as a subcutaneous injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants who discontinue enfuvirtide due to adverse events\n | Up to 102 weeks | |
| Percentage ofparticipants who discontinue from tratment since they no longer wish to continue with the injections | Up to 102 weeks | |
| Percentage of participants with Serious Adverse Events (SAEs) and Serious AIDS-Defining events | Up to 102 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage os participants reporting serious adverse events on the first day of study dosing and up to 28 days after discontinuiation of the study drug | Up to 28 days after discontinuation of enfuvirtide | |
| Percentage of participants with Injection Site Reactions (ISR) and who discontinued enfuvirtide due to ISR |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sofia | 1431 | Bulgaria |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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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 |
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| Up to 102 weeks |
| 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 |
| 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 |