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.
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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.
|Publication 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|
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