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