HRG2 is a Phase 2 randomized, controlled, open-label, multi-dose trial to determine the
efficacy, safety, immunogenicity, and pharmacokinetic profile of PEHRG214 in HIV-infected
patients, treated three times weekly for up to 16 weeks.
All patients are receiving optimized standard of care HAART.
The primary objective of the study is to determine the effect of PEHRG214 in decreasing the
viral load (>=1.0 log10), as compared to a Control group. The primary hypothesis is that
treatment with PEHRG214 will result in clinically meaningful and sustained viral load
suppression.
The total sample size is 70-74 patients from approximately 8-10 participating study centers.
The first 16-20 patients are enrolled in the non-randomized "pilot arm" and 54 subsequent
patients are randomized (2:1 within center) to Treatment or Control group. The total study
duration is 7-12 months.