A Study to Evaluate the Safety and Effectiveness of WF10 Given to Patients With Late-Stage HIV Disease
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Pivotal Clinical Study Evaluating the Safety and Efficacy of WF10 (TCDO) Intravenous Solution in the Management of Patients With Late-Stage HIV Disease
1 other identifier
interventional
240
2 countries
32
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 hiv-infections
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
March 1, 2001
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients may be eligible for this study if they:
- Are HIV-positive.
- Have a CD4 cell count of less than 50 cells/mm3 within 14 days prior to study entry.
- Are at least 18 years old.
- Have received anti-HIV drugs at some time in the past.
- Agree to practice abstinence or use effective methods of birth control, including the pill, during the study.
You may not qualify if:
- Patients will not be eligible for this study if they:
- Are being treated for any form of cancer within 30 days of study entry.
- Have ever received an HIV vaccine.
- Have received steroids within 30 days prior to study entry. (Note: Testosterone is allowed.)
- Have received certain medications, including anti-HIV treatments that are not approved by the FDA.
- Have participated in another WF10 study.
- Have an illness or any condition that might exclude them from this study.
- Are pregnant or breast-feeding.
- Abuse drugs or medications.
- Received a blood transfusion within 45 days prior to study entry.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- OXO Chemielead
Study Sites (32)
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Tower Infectious Disease Med Ctr
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