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

NCT ID: NCT00002244

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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WF10

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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OXO Chemie

INDUSTRY

Sponsor Role lead

Locations

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Univ of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Tower Infectious Disease Med Ctr

Los Angeles, California, United States

Site Status

Highland Gen Hosp / San Francisco Gen Hosp

Oakland, California, United States

Site Status

ViRx Inc

San Francisco, California, United States

Site Status

UCSF - San Francisco Gen Hosp

San Francisco, California, United States

Site Status

George Washington Univ Med Ctr

Washington D.C., District of Columbia, United States

Site Status

Univ of Miami School of Medicine

Miami, Florida, United States

Site Status

Hillsborough County Health Dept

Tampa, Florida, United States

Site Status

Ctr for Quality Care

Tampa, Florida, United States

Site Status

AIDS Research Consortium of Atlanta

Atlanta, Georgia, United States

Site Status

Leahi Hosp / Univ of Hawaii

Honolulu, Hawaii, United States

Site Status

Northwestern Univ Med School

Chicago, Illinois, United States

Site Status

Rush Med Ctr / Section of Infectious Diseases

Chicago, Illinois, United States

Site Status

The CORE Ctr

Chicago, Illinois, United States

Site Status

Univ of Iowa Hosp & Clinic

Iowa City, Iowa, United States

Site Status

Boston Med Ctr / Clinical Research Office

Boston, Massachusetts, United States

Site Status

Univ Health Ctr

Detroit, Michigan, United States

Site Status

Regions Hosp

Saint Paul, Minnesota, United States

Site Status

Truman Med Ctr / Infectious Disease Clinic

Kansas City, Missouri, United States

Site Status

Newark Community Health Ctr

Newark, New Jersey, United States

Site Status

Univ of New Mexico Health Science Center

Albuquerque, New Mexico, United States

Site Status

Associates in Med and Mental Health

Tulsa, Oklahoma, United States

Site Status

MCP Hahnemann Univ

Philadelphia, Pennsylvania, United States

Site Status

Ludwig Lettau Private Practice

Charleston, South Carolina, United States

Site Status

Burnside Clinic

Columbia, South Carolina, United States

Site Status

Hampton Roads Med Specialists

Hampton, Virginia, United States

Site Status

Virginia Mason Research Center / Clinical Trial Unit

Seattle, Washington, United States

Site Status

St Paul's Hosp

Vancouver, British Columbia, Canada

Site Status

QEII Health Science Centre

Halifax, Nova Scotia, Canada

Site Status

Ottawa General Hospital

Ottawa, Ontario, Canada

Site Status

Sunnybrook Health Science Ctr

Toronto, Ontario, Canada

Site Status

Montreal Gen Hosp / Div of Clin Immuno and Allergy

Montreal, Quebec, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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222C

Identifier Type: -

Identifier Source: org_study_id