Long-term randomised comparison of clinical outcomes following ART initiation with triple-nucleoside (Combivir/Abacavir) or NNRTI-based (Combivir/Nevirapine) therapy in Africa: the NORA substudy of the DART trial.

Abstract

This conference poster presents the results of the NORA substudy of the DART trial, which involved 600 patients randomised to initiate antiretroviral therapy (ART) with ZDV+3TC (Combivir, CBV) plus Abacavir (ABC) or Nevirapine (NVP). Primary and secondary endpoints were toxicity at 24 weeks (placebo-blinded), with continued open-label follow-up after 24 weeks for up to 5 years in DART. The study found there was no statistically significant difference in the rate of new WHO 4 events/death or death between participants initiating ART with Combivir plus Neverapine versus Abacavir through 5 years follow up. Including time-dependent factors in multivariable models is the standard method for adjustment in observational anaylses, but provides incomplete adjustment for time-dependent confounders.

Citation

Walker, A.S.; Munderi, P.; Kityo, C.; Babiker, A.G.; Ssali, F.; Reid, A.; Grosskurth, H.; Mugyenyi, P.; Gibb, D.M.; Gilks, C.F. Long-term randomised comparison of clinical outcomes following ART initiation with triple-nucleoside (Combivir/Abacavir) or NNRTI-based (Combivir/Nevirapine) therapy in Africa: the NORA substudy of the DART trial. Presented at the 5th IAS Conference on HIV Pathogenesis, Treatment and Prevention, Cape Town, South Africa, 19-22 July 2009. (2009) 1 pp.

Long-term randomised comparison of clinical outcomes following ART initiation with triple-nucleoside (Combivir/Abacavir) or NNRTI-based (Combivir/Nevirapine) therapy in Africa: the NORA substudy of the DART trial.

Published 1 January 2009