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 infection: Ozcombo 1 and 2

Amin, J, Moore, A, Carr, A, French, MA, Law, M, Emery, S and Cooper, DA (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 infection: Ozcombo 1 and 2. HIV Clinical Trials, 4 4: 252-261. doi:10.1310/K2U9-QC2V-1Y3V-5DYF


Author Amin, J
Moore, A
Carr, A
French, MA
Law, M
Emery, S
Cooper, DA
Title 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 infection: Ozcombo 1 and 2
Journal name HIV Clinical Trials   Check publisher's open access policy
ISSN 1528-4336
1945-5771
Publication date 2003-01-01
Sub-type Article (original research)
DOI 10.1310/K2U9-QC2V-1Y3V-5DYF
Open Access Status Not yet assessed
Volume 4
Issue 4
Start page 252
End page 261
Total pages 10
Place of publication Abingdon, Oxfordshire, United Kingdom
Publisher Taylor & Francis
Language eng
Formatted abstract
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/μL and log copies HIV RNA/mL adjusted for baseline CD4+ T-cell and HIV RNA counts were: –44 (p = .08) and –14 (p = .56) cells/μL and –0.1 (p = .40) and –0.1 (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.
Keyword Antiretroviral therapy
Highly active
HIV-1
Lipodystrophy
Meta-analysis
Virological failure
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Article (original research)
Collection: School of Medicine Publications
 
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