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

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.