Study protocol | Date | Sample size | Follow-up | Major inclusion criteria |
---|---|---|---|---|
Original | 12/02/2008 | 128 | 48 weeks | Viral load <50 copies/ml in the last 6 months; No history of virologic rebound; CD4+ T cell counts ≥400 cells/μl; Pre-HAART CD4+ nadir >250 cells/μl No history of AIDS-related opportunistic or neoplastic disease; No concomitant treatment for HBV or HCV infections |
First amendment | 24/11/2009 | 160 | 144 weeks | Viral load <50 copies/ml in the last 6 months; Allowed history of virologic rebound; CD4+ T cell counts ≥200 cells/μl; Any pre-HAART CD4+ nadir; Allowed history of AIDS-related opportunistic or neoplastic disease; HBV or HCV co-infections were allowed |
Second amendment | 20/07/2012 | 160 | 48Â weeks | Same criteria of the first amendment |