A Study to Evaluate the Safety and Effectiveness of WF10 Given to Patients With Late-Stage HIV Disease
- Conditions
- HIV Infections
- Registration Number
- NCT00002244
- Lead Sponsor
- OXO Chemie
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 240
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (32)
Univ of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Tower Infectious Disease Med Ctr
🇺🇸Los Angeles, California, United States
Highland Gen Hosp / San Francisco Gen Hosp
🇺🇸Oakland, California, United States
ViRx Inc
🇺🇸San Francisco, California, United States
UCSF - San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
George Washington Univ Med Ctr
🇺🇸Washington, District of Columbia, United States
Univ of Miami School of Medicine
🇺🇸Miami, Florida, United States
Hillsborough County Health Dept
🇺🇸Tampa, Florida, United States
Ctr for Quality Care
🇺🇸Tampa, Florida, United States
AIDS Research Consortium of Atlanta
🇺🇸Atlanta, Georgia, United States
Scroll for more (22 remaining)Univ of Alabama at Birmingham🇺🇸Birmingham, Alabama, United States