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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.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002244
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: March 2001

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002244 on ClinicalTrials.gov Archive Site
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A Study to Evaluate the Safety and Effectiveness of WF10 Given to Patients With Late-Stage HIV Disease
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.

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.

Interventional
Phase 3
Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
HIV Infections
Drug: WF10
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
240
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00002244
222C
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OXO Chemie
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NIH AIDS Clinical Trials Information Service
March 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP