Table 1.

Patient eligibility criteria for PASER-M and TASER-M

Inclusion criteria

Confirmed HIV-1 infection

≥18 years of age

Eligiblea for initiation of a first-line ART regimen or switch from a first-line ART regimen (containing at least three antiretroviral drugs and taken for ≥6 months) to a second-line ART regimen due to virological, immunological and/or clinical failure

Signed informed consent for study participation prior to enrolment

Exclusion criteria

Currently taking ART (minimum of three-drug regimen), if initiating a first-line ART regimenb

Pregnancy at enrolmentc

HIV-1/2 dual infection (in endemic countries only)c

^aEligibility for ART initiation defined in accordance with national ART guidelines (i.e. advanced immunodeficiency as defined by CD4 cell count less than 200 or less than 350 cells/µl, or advanced clinical disease according to WHO clinical stage/CDC classification).

^bSpecified PASER-M definition: re-initiation of a first-line ART regimen <30 days after stopping previous first-line ART (previous use of antiretroviral prophylaxis or mono/dual therapy is not an exclusion criterion).

^cExclusion criteria applicable to PASER-M only.