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The purpose of this study is to see if it is safe and effective to give WF10 to adults with late-stage HIV disease. WF10 is suspected to help the immune system fight infection and slow HIV disease progression.
Patients are randomized to 1 of 2 treatment groups to receive 4 IV treatment cycles of either WF10 or control (physiological saline solution). Patients are monitored throughout the study for: a) clinical progression; b) number, duration, and cause of hospitalizations; c) quality of life; and d) density of CD38 antigen on CD8+ T cells. Patients receive treatment for 11 weeks but will continue to be followed for a maximum of 96 weeks. During the follow-up period, patients are evaluated initially at Week 18, then at Weeks 24, 36, and 48. If the study is continued beyond Week 48, follow-up visits are conducted at Weeks 72 and 96.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WF10 | Drug |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univ of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Tower Infectious Disease Med Ctr |
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| Los Angeles |
| California |
| 90048 |
| United States |
| Highland Gen Hosp / San Francisco Gen Hosp | Oakland | California | 946021018 | United States |
| ViRx Inc | San Francisco | California | 94103 | United States |
| UCSF - San Francisco Gen Hosp | San Francisco | California | 94110 | United States |
| George Washington Univ Med Ctr | Washington D.C. | District of Columbia | 20037 | United States |
| Univ of Miami School of Medicine | Miami | Florida | 33136 | United States |
| Hillsborough County Health Dept | Tampa | Florida | 33602 | United States |
| Ctr for Quality Care | Tampa | Florida | 33609 | United States |
| AIDS Research Consortium of Atlanta | Atlanta | Georgia | 30308 | United States |
| Leahi Hosp / Univ of Hawaii | Honolulu | Hawaii | 96816 | United States |
| Northwestern Univ Med School | Chicago | Illinois | 60611 | United States |
| Rush Med Ctr / Section of Infectious Diseases | Chicago | Illinois | 60612 | United States |
| The CORE Ctr | Chicago | Illinois | 60612 | United States |
| Univ of Iowa Hosp & Clinic | Iowa City | Iowa | 52242 | United States |
| Boston Med Ctr / Clinical Research Office | Boston | Massachusetts | 02118 | United States |
| Univ Health Ctr | Detroit | Michigan | 48201 | United States |
| Regions Hosp | Saint Paul | Minnesota | 55101 | United States |
| Truman Med Ctr / Infectious Disease Clinic | Kansas City | Missouri | 64108 | United States |
| Newark Community Health Ctr | Newark | New Jersey | 07114 | United States |
| Univ of New Mexico Health Science Center | Albuquerque | New Mexico | 87131 | United States |
| Associates in Med and Mental Health | Tulsa | Oklahoma | 74114 | United States |
| MCP Hahnemann Univ | Philadelphia | Pennsylvania | 19102 | United States |
| Ludwig Lettau Private Practice | Charleston | South Carolina | 29414 | United States |
| Burnside Clinic | Columbia | South Carolina | 29206 | United States |
| Hampton Roads Med Specialists | Hampton | Virginia | 23666 | United States |
| Virginia Mason Research Center / Clinical Trial Unit | Seattle | Washington | 98101 | United States |
| St Paul's Hosp | Vancouver | British Columbia | Canada |
| QEII Health Science Centre | Halifax | Nova Scotia | Canada |
| Ottawa General Hospital | Ottawa | Ontario | Canada |
| Sunnybrook Health Science Ctr | Toronto | Ontario | Canada |
| Montreal Gen Hosp / Div of Clin Immuno and Allergy | Montreal | Quebec | Canada |
| 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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