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

This study has been completed.

Sponsored by: OXO Chemie
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002244
  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 III

MedlinePlus related topics:   AIDS   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Double-Blind, Safety Study
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

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

Show 32 study locations  Show 32 Study Locations

Sponsors and Collaborators
OXO Chemie
  More Information


Study ID Numbers:   222C
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002244
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  

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Quality of Life
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on December 03, 2008




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