Clinical Trial 8553

Burbank, CA 91505

Study Summary:

This is a double-blind, placebo-controlled, dose escalation study of KD-247 in asymptomatic HIV-1 seropositive subjects who do not currently need antiretroviral therapy. Eligible subjects will be randomized to 1 of 3 cohorts and will receive 3 infusions of 4, 8 or 16 mg/kg of KD-247 or placebo over a 2-week period. A maximum of 9 active subjects and 3 placebo subjects will be allowed per cohort. Study duration is approximately 4 months (including up to 8 weeks, but not less than 3 weeks between screening and baseline, plus a 12-16 week follow-up period after the final infusion of study drug.)

Qualified Participants Must:

• Be 18-64 years of age
• Have HIV viral load between 1000 and 100,000copies/mL
• Have CD4 cell count of >350 cells/mm
• Be treatment naive, or off antiretroviral drugs for at least 8 weeks prior to screening
• Have a viral genotype sequence that conforms with the principal neutralizing determinant of KD-247 (will be determined by genotype testing)

Qualified Participants May Receive:

Physical Exam, all lab and blood work, ECG, possible financial compensation for time and travel up to $100 a visit.

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.