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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002244
• Other study ID #: 222C
• Status: Completed
• Phase: Phase 3
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: March 2001
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• WF10

Locations

Country	Name	City	State
Canada	QEII Health Science Centre	Halifax	Nova Scotia
Canada	Montreal Gen Hosp / Div of Clin Immuno and Allergy	Montreal	Quebec
Canada	Ottawa General Hospital	Ottawa	Ontario
Canada	Sunnybrook Health Science Ctr	Toronto	Ontario
Canada	St Paul's Hosp	Vancouver	British Columbia
United States	Univ of New Mexico Health Science Center	Albuquerque	New Mexico
United States	AIDS Research Consortium of Atlanta	Atlanta	Georgia
United States	Univ of Alabama at Birmingham	Birmingham	Alabama
United States	Boston Med Ctr / Clinical Research Office	Boston	Massachusetts
United States	Ludwig Lettau Private Practice	Charleston	South Carolina
United States	Northwestern Univ Med School	Chicago	Illinois
United States	Rush Med Ctr / Section of Infectious Diseases	Chicago	Illinois
United States	The CORE Ctr	Chicago	Illinois
United States	Burnside Clinic	Columbia	South Carolina
United States	Univ Health Ctr	Detroit	Michigan
United States	Hampton Roads Med Specialists	Hampton	Virginia
United States	Leahi Hosp / Univ of Hawaii	Honolulu	Hawaii
United States	Univ of Iowa Hosp & Clinic	Iowa City	Iowa
United States	Truman Med Ctr / Infectious Disease Clinic	Kansas City	Missouri
United States	Tower Infectious Disease Med Ctr	Los Angeles	California
United States	Univ of Miami School of Medicine	Miami	Florida
United States	Newark Community Health Ctr	Newark	New Jersey
United States	Highland Gen Hosp / San Francisco Gen Hosp	Oakland	California
United States	MCP Hahnemann Univ	Philadelphia	Pennsylvania
United States	UCSF - San Francisco Gen Hosp	San Francisco	California
United States	ViRx Inc	San Francisco	California
United States	Virginia Mason Research Center / Clinical Trial Unit	Seattle	Washington
United States	Regions Hosp	St. Paul	Minnesota
United States	Ctr for Quality Care	Tampa	Florida
United States	Hillsborough County Health Dept	Tampa	Florida
United States	Associates in Med and Mental Health	Tulsa	Oklahoma
United States	George Washington Univ Med Ctr	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
OXO Chemie

Countries where clinical trial is conducted

United States,  Canada,