A Study to Evaluate the Safety and Effectiveness of WF10 Given to Patients With Late-Stage HIV Disease - Full Text View

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: WF10	Phase 3

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Masking: Double-Blind Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:

240

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002244

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Locations

United States, Alabama
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Tower Infectious Disease Med Ctr
Los Angeles, California, United States, 90048
Highland Gen Hosp / San Francisco Gen Hosp
Oakland, California, United States, 946021018
ViRx Inc
San Francisco, California, United States, 94103
UCSF - San Francisco Gen Hosp
San Francisco, California, United States, 94110
United States, District of Columbia
George Washington Univ Med Ctr
Washington, District of Columbia, United States, 20037
United States, Florida
Univ of Miami School of Medicine
Miami, Florida, United States, 33136
Ctr for Quality Care
Tampa, Florida, United States, 33609
Hillsborough County Health Dept
Tampa, Florida, United States, 33602
United States, Georgia
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
United States, Hawaii
Leahi Hosp / Univ of Hawaii
Honolulu, Hawaii, United States, 96816
United States, Illinois
Rush Med Ctr / Section of Infectious Diseases
Chicago, Illinois, United States, 60612
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
The CORE Ctr
Chicago, Illinois, United States, 60612
United States, Iowa
Univ of Iowa Hosp & Clinic
Iowa City, Iowa, United States, 52242
United States, Massachusetts
Boston Med Ctr / Clinical Research Office
Boston, Massachusetts, United States, 02118
United States, Michigan
Univ Health Ctr
Detroit, Michigan, United States, 48201
United States, Minnesota
Regions Hosp
St. Paul, Minnesota, United States, 55101
United States, Missouri
Truman Med Ctr / Infectious Disease Clinic
Kansas City, Missouri, United States, 64108
United States, New Jersey
Newark Community Health Ctr
Newark, New Jersey, United States, 07114
United States, New Mexico
Univ of New Mexico Health Science Center
Albuquerque, New Mexico, United States, 87131
United States, Oklahoma
Associates in Med and Mental Health
Tulsa, Oklahoma, United States, 74114
United States, Pennsylvania
MCP Hahnemann Univ
Philadelphia, Pennsylvania, United States, 19102
United States, South Carolina
Ludwig Lettau Private Practice
Charleston, South Carolina, United States, 29414
Burnside Clinic
Columbia, South Carolina, United States, 29206
United States, Virginia
Hampton Roads Med Specialists
Hampton, Virginia, United States, 23666
United States, Washington
Virginia Mason Research Center / Clinical Trial Unit
Seattle, Washington, United States, 98101
Canada, British Columbia
St Paul's Hosp
Vancouver, British Columbia, Canada
Canada, Nova Scotia
QEII Health Science Centre
Halifax, Nova Scotia, Canada
Canada, Ontario
Ottawa General Hospital
Ottawa, Ontario, Canada
Sunnybrook Health Science Ctr
Toronto, Ontario, Canada
Canada, Quebec
Montreal Gen Hosp / Div of Clin Immuno and Allergy
Montreal, Quebec, Canada

Sponsors and Collaborators

OXO Chemie

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00002244 History of Changes
Other Study ID Numbers:	222C
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Placebos
Infusions, Intravenous
Quality of Life
Anti-HIV Agents
tetrachlorodecaoxide

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases

Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on June 18, 2013