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Table 10 Clinical study protocol and amendments

From: HIV-1 Tat immunization restores immune homeostasis and attacks the HAART-resistant blood HIV DNA: results of a randomized phase II exploratory clinical trial

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

48 weeks

Same criteria of the first amendment