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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a retrospective chart review of 5 patients from a CAPRISA TRuTH study (NCT01539005), two men and three women, aged 30−38 years were described, who developed drug resistance during antiretroviral treatment (ART) as per CAPRISA SAPiT trial with abacavir, didanosine, efavirenz, lamivudine, lopinavir/ritonavir, tenofovir disoproxil fumarate or zidovudine for HIV and tuberculosis co-infection [routes, doses, durations of treatments to reactions onsets and outcomes stated].
Patient 1: A 38-year-old man, who had a history of alcohol abuse was diagnosed with HIV and tuberculosis (TB) infection in July 2007 and was hospitalised. He received standard TB treatment according to the South African National TB control program guidelines (details not specified). He started receiving...
- Dookie N, et al. Recurrent tuberculosis among HIV-coinfected patients: A case series from KwaZulu-Natal. Infection and Drug Resistance 11: 1413-1421, Jan 2018. Available from: URL: http://doi.org/10.2147/IDR.S150644 - South Africa