Back to resultsA Study to Evaluate the Safety and Effectiveness of WF10 Given to Patients With Late-Stage HIV Disease
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
WF10
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Placebos, Infusions, Intravenous, Quality of Life, Anti-HIV Agents, tetrachlorodecaoxide
Eligibility Criteria
Inclusion Criteria 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. Exclusion Criteria 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.
Sites / Locations
- Univ of Alabama at Birmingham
- Tower Infectious Disease Med Ctr
- Highland Gen Hosp / San Francisco Gen Hosp
- ViRx Inc
- UCSF - San Francisco Gen Hosp
- George Washington Univ Med Ctr
- Univ of Miami School of Medicine
- Hillsborough County Health Dept
- Ctr for Quality Care
- AIDS Research Consortium of Atlanta
- Leahi Hosp / Univ of Hawaii
- Northwestern Univ Med School
- Rush Med Ctr / Section of Infectious Diseases
- The CORE Ctr
- Univ of Iowa Hosp & Clinic
- Boston Med Ctr / Clinical Research Office
- Univ Health Ctr
- Regions Hosp
- Truman Med Ctr / Infectious Disease Clinic
- Newark Community Health Ctr
- Univ of New Mexico Health Science Center
- Associates in Med and Mental Health
- MCP Hahnemann Univ
- Ludwig Lettau Private Practice
- Burnside Clinic
- Hampton Roads Med Specialists
- Virginia Mason Research Center / Clinical Trial Unit
- St Paul's Hosp
- QEII Health Science Centre
- Ottawa General Hospital
- Sunnybrook Health Science Ctr
- Montreal Gen Hosp / Div of Clin Immuno and Allergy
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00002244
Brief Title
A Study to Evaluate the Safety and Effectiveness of WF10 Given to Patients With Late-Stage HIV Disease
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2001
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
OXO Chemie
4. Oversight
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Placebos, Infusions, Intravenous, Quality of Life, Anti-HIV Agents, tetrachlorodecaoxide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double
Enrollment
240 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
WF10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
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.
Exclusion Criteria
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.
Facility Information:
Facility Name
Univ of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Tower Infectious Disease Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Highland Gen Hosp / San Francisco Gen Hosp
City
Oakland
State/Province
California
ZIP/Postal Code
946021018
Country
United States
Facility Name
ViRx Inc
City
San Francisco
State/Province
California
ZIP/Postal Code
94103
Country
United States
Facility Name
UCSF - San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
George Washington Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Univ of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Hillsborough County Health Dept
City
Tampa
State/Province
Florida
ZIP/Postal Code
33602
Country
United States
Facility Name
Ctr for Quality Care
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
AIDS Research Consortium of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Leahi Hosp / Univ of Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96816
Country
United States
Facility Name
Northwestern Univ Med School
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush Med Ctr / Section of Infectious Diseases
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
The CORE Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Univ of Iowa Hosp & Clinic
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Boston Med Ctr / Clinical Research Office
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Univ Health Ctr
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Regions Hosp
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
Truman Med Ctr / Infectious Disease Clinic
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Newark Community Health Ctr
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07114
Country
United States
Facility Name
Univ of New Mexico Health Science Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Associates in Med and Mental Health
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74114
Country
United States
Facility Name
MCP Hahnemann Univ
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Ludwig Lettau Private Practice
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Burnside Clinic
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29206
Country
United States
Facility Name
Hampton Roads Med Specialists
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
Country
United States
Facility Name
Virginia Mason Research Center / Clinical Trial Unit
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
St Paul's Hosp
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
QEII Health Science Centre
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
Ottawa General Hospital
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Sunnybrook Health Science Ctr
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Montreal Gen Hosp / Div of Clin Immuno and Allergy
City
Montreal
State/Province
Quebec
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Safety and Effectiveness of WF10 Given to Patients With Late-Stage HIV Disease
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