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| ID | Type | Description | Link |
|---|---|---|---|
| TRI-003 |
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The purpose of this study is to see if it is safe and effective to give T-20 to HIV-positive adults. T-20 is an anti-HIV drug.
Patients are randomly placed into 1 of 6 groups: 4 dose levels of T-20 are given by subcutaneous infusion and 2 by subcutaneous injection. The entire study lasts 7 weeks; including a 2-week screening period, followed by 28 days of treatment and 1 week of follow-up.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enfuvirtide | Drug |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
HIV-1 seropositive status.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent neoplasm (except for basal cell carcinoma of the skin, in situ carcinoma of the cervix, and non-disseminated stable Kaposi's sarcoma).
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
- Prior treatment with an HIV vaccine.
Prior Treatment:
Excluded:
Major organ allograft.
Risk Behavior:
Excluded:
Evidence of substance abuse or addiction that, in the opinion of the investigator, may interfere with the patient's ability to comply with the dosing schedule and protocol evaluations.
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| Name | Affiliation | Role |
|---|---|---|
| Sam Hopkins | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univ of Alabama at Birmingham / 1917 AIDS O/P Cln | Birmingham | Alabama | 35294 | United States | ||
| UCLA School of Medicine / Ctr for Research and Education |
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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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| Los Angeles |
| California |
| 900951793 |
| United States |
| San Francisco Gen Hosp | San Francisco | California | 94110 | United States |
| Quest Clinical Research | San Francisco | California | 94115 | United States |
| IDC Research Initiative | Altamonte Springs | Florida | 32701 | United States |
| Northwestern Univ / Infect Dis Div / Pasavant Pav 828 | Chicago | Illinois | 60611 | United States |
| Johns Hopkins Hosp | Baltimore | Maryland | 21287 | United States |
| CRI of New England | Brookline | Massachusetts | 02445 | United States |
| NYU Med Ctr / C & D Building | New York | New York | 10016 | United States |
| Univ North Carolina at Chapel Hill / Dept of Medicine | Chapel Hill | North Carolina | 27599 | United States |
| Univ of Texas / Thomas Street Clinic | Houston | Texas | 77030 | United States |
| 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 |