The primary objective of the trial is: • to evaluate the change from baseline in plasma viral load with placebo and one of up to 4 dose regimens of RDEA806. The secondary objectives are: Efficacy * to describe the nadir of the plasma viral load * to describe the DAVG * to assess the proportion of subjects who reached a drop in viral load of 0.5 log, 1 log, or reach an undetectable viral load * to assess the plasma viral load decay rate * to evaluate immunologic changes (as measured by CD4 and CD8 cells) * to evaluate the genotypic and phenotypic pattern of the virus Pharmacokinetics * to evaluate the pharmacokinetics and the pharmacokinetic/pharmacodynamic relationship of RDEA806 Safety * to evaluate the safety and tolerability of bid and qd dosing of RDEA806 as monotherapy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Placebo
Unnamed facility
Hamburg, Germany
Unnamed facility
London, United Kingdom
Change from baseline in HIV plasma viral load
Time frame: 9 days
Safety will be assessed as adverse and HIV related events, clinical laboratory test results(hematology, chemistry, urinalysis), vital signs, 12-lead electrocardiograms (ECGs), and physical examination
Time frame: 22 days
Pharmacokinetics and Resistance
Time frame: 22 days
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