Murdoch University Research Repository

Welcome to the Murdoch University Research Repository

The Murdoch University Research Repository is an open access digital collection of research
created by Murdoch University staff, researchers and postgraduate students.

Learn more

Combined analysis of Two-Year Follow-up from two open-label randomized trials comparing efficacy of three nucleoside reverse transcriptase inhibitor backbones for previously untreated HIV-1 nfection: OzCombo 1 and 2

Amin, J., Moore, A., Carr, A., French, M.A., Law, M., Emery, S., Cooper, D.A., Kotsiou, G., Norrito, L., Dwyer, D., Packham, D., Fordham, M., Garsia, R., Baker, D., Doong, N.C., Quan, D., Beveridge, A., Genn, W., Quin, J., Mulholland, J., Sowden, D., Rawlinsen, M., Rebic, D., Street, A., De Graaf, B., Roney, J., Bryant, M., McCormack, C., Hoy, J.N., Shaw, D.V., Ferguson, W., Waddell, R., Papanaoum, K., French, M.R., Scull, N., Todhunter, L., Mallal, S., James, R. and Foreman, E. (2003) Combined analysis of Two-Year Follow-up from two open-label randomized trials comparing efficacy of three nucleoside reverse transcriptase inhibitor backbones for previously untreated HIV-1 nfection: OzCombo 1 and 2. HIV Clinical Trials, 4 (4). pp. 252-261.

[img]
Preview
PDF - Published Version
Download (562kB)
Link to Published Version: http://dx.doi.org/10.1310/K2U9-QC2V-1Y3V-5DYF
*Subscription may be required

Abstract

Purpose: To compare inhibition of HIV replication, improvements in CD4+ T-cell counts, metabolic parameters, and body shape changes after 2 years of assigned therapy in OzCombo patients. Method: Study participants were those who were recruited into the open-label OzCombo 1 (1996/1997) and OzCombo 2 (1997/1998) trials. Patients in OzCombo 1 were randomized to receive indinavir in combination with zidovudine+lamivudine (AZT+3TC; n = 35), stavudine (d4T)+3TC (n = 34), or d4T+didanosine (ddI) (n = 37). OzCombo 2 patients were randomized to the same nucleoside reverse transcriptase inhibitor (NRTI) backbones with nevirapine (n = 20, 22, 23, respectively). The mean time-weighted changes from baseline in CD4 T-cell count/mL, HIV RNA (log copies/mL plasma), and proportions with detectable viral load (<500 copies plasma HIV RNA/mL) between NRTI arms over 2 years were compared by formal meta-analysis. A cross-sectional study of metabolic and body shape complications was also undertaken. Results: For the comparison of d4T+3TC and d4T+ddI to AZT+3TC, mean differences in time-weighted change from baseline in CD4 T-cell count/wL and log copies HIV RNA/mL adjusted for baseline CD4+ T-cell and HIV RNA counts were: m44 (p = .08) and m14 (p = .56) cells/wL and m0.1 (p = .40) and m0.1 (p = .6) copies/mL. Odds ratios for detectable viral load in the last study quarter were 0.6 (p = .44) and 1.0 (p = .95). The mean percent leg fat was lower in the d4T+3TC and d4T+ddI than the AZT+3TC arm (mean difference 5.1% [p = .07] and 7.6% [p = .02], respectively). Conclusion: For all regimens, virological control and immunological response were maintained over 2 years. Regimens containing d4T and particularly d4T+ddI were significantly associated with increased peripheral fat loss compared with AZT+3TC.

Item Type: Journal Article
Murdoch Affiliation: Centre for Clinical Immunology and Biomedical Statistics
Publisher: Thomas Land Publishers Inc.
Notes: Simon Mallal appears as part of the OzCombo 1 and 2 investigators
URI: http://researchrepository.murdoch.edu.au/id/eprint/14946
Item Control Page Item Control Page

Downloads

Downloads per month over past year