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

June 23, 2005 updated by: OXO Chemie

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

240

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Masking: DOUBLE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (ESTIMATE)

August 31, 2001

Study Record Updates

Last Update Posted (ESTIMATE)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

March 1, 2001

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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