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. Author manuscript; available in PMC: 2011 Jul 28.
Published in final edited form as: Lancet. 2010 Jul 3;376(9734):33–40. doi: 10.1016/S0140-6736(10)60894-X

Table 2. Cumulative treatment failure (primary end-point) and accompanying reasons by study arm for 812 subjects randomised to doctor or nurse monitored antiretroviral therapy in the CIPRA-SA trial in South Africa.

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The two arms of the study were compared using a composite end-point or cumulative treatment failure. The composite consisted of each of the reasons listed below.

Early virologic failure was defined when a participant failed to demonstrate a serologic viral load decline of more than 1.5 logarithm within 12 weeks of initiating treatment.

*

Late virologic failure was defined as rebound in viral load from undetectable to more than 1000 copies/ml confirmed within one month.

**

Any loss was defined as: 1) withdrawn consent was if the patient withdrew from participating in the study for whatever reason and represents in most cases a transfer away from the site to another geographic location and clinic; 2) defaulting clinic schedule was a protocol defined measure of adherence to the clinic schedule, any participant who missed three consecutive visits was considered to be defaulting; (3) Loss to follow-up was consider if a participant did not return to the clinic for three consecutive clinic visits and could not be traced.