The New Era Study is an ongoing prospective 7-year clinical trial initiated in 2009 using 5-drug cART (combination antiretroviral therapy) in patients with primary HIV infection (PHI, ≤2 Western blot bands) and in patients with chronic HIV-infection on suppressive PI-based HAART for ≥3 years without prior virologic failure (CHI). The primary objectives of the study were to halt residual viral replication in plasma and to achieve depletion of cell-associated HIV-DNA (‘proviral DNA’) as a step towards (functional) HIV cure which could be proven by treatment interruption. The primary and secondary outcome measures of the New Era Study are cell-associated HIV-DNA copies per 10exp6 peripheral blood mononuclear cells (PBMC), plasma HIV-RNA level, absolute and relative CD4+ and CD8+ T-cell counts, CD4/CD8 ratio, and CD8+CD38+ T-cell count. The implementation of Amendment 1.0 comprising the measurement of additional laboratory parameters does not affect primary objectives but secondary objectives are amended. The rationale for amending additional laboratory markers to be measured is based on new questions arising from intensified worldwide cure research since the beginning of the New Era Study. According to the study protocol, treatment can be interrupted in case of plasma HIV-RNA <50 cop./ml for ≥5 years, undetectable HIV-RNA using single-copy assay for ≥2 years coupled with undetectable proviral DNA levels in PBMC for ≥2 years. As shown by the Visconti post-treatment controllers and other case reports of post treatment controlling (PTC) further virologic, immunologic and genetic markers are needed to better predict virus control after treatment interruption (Saez-Cirion 2013). Therefore, the measurement of laboratory parameters (one additional blood sampling per patient) will be extended in the population of the New Era Study in order to better characterize and discriminate these patients in terms of immunologic and virologic parameters.