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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Primary Purpose: Treatment
    • Masking: Double

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.

Interventions

  • Drug: WF10

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • OXO Chemie

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