Different types of treatment failure:
(1) clinical
(2) CD4 positive lymphocyte count
(3) virological
Criteria for clinical failure:
(1) one or more of the following:
(1a) recurrence of a WHO Stage 4 condition indicative of treatment failure
(1b) onset of a new WHO Stage 4 condition indicative of treatment failure
(1c) recurrence of a WHO Stage 3 condition indicative of treatment failure (tuberculosis, severe bacterial infection)
(1d) onset of a WHO Stage 3 condition indicative of treatment failure
(2) exclusion of immune reconstitution inflammatory syndrome (IRIS) as the cause of a change in clinical status
where:
• Some Stage 4 conditions may not indicate treatment failure - tuberculous pleuritis, recurrent bacterial pneumonia, tuberculous lymphadenitis).
CD4 positive lymphocyte count - one or more of the following:
(1) absolute count persistently < 100 per µL
(2) 50% drop in absolute count from maximum levels while on treatment
(3) drop in absolute count below baseline seen before treatment started
Virological failure:
(1) plasma HIV viral load > 10,000 per mL (LOG10 > 4)
Additional suggestion (not in original criteria):
(1) identification of a drug resistant strain
