Clinical trial NCT00002244: A Study to Evaluate the Safety and Effectiveness of WF10 Given to Patients With Late-Stage HIV Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: Placebos
Infusions, Intravenous
Quality of Life
Anti-HIV Agents
tetrachlorodecaoxide
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

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