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

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002244 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Study to Evaluate the Safety and Effectiveness of WF10 Given to Patients With Late-Stage HIV Disease
Official Title ^ICMJE	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
Brief Summary	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.
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 Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Double-Blind, Safety Study
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: WF10
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	240
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Canada

Administrative Information
NCT ID ^ICMJE	NCT00002244
Responsible Party
Study ID Numbers ^ICMJE	222C
Study Sponsor ^ICMJE	OXO Chemie
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	March 2001
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP