A Study to Evaluate the Safety and Effectiveness of WF10 Given to Patients With Late-Stage HIV Disease
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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.
Condition or disease
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.
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
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients may be eligible for this study if they:
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.
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.