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Randomized, open-label, comparative trial to evaluate the efficacy and safety of three antiretroviral drug combinations including two nucleoside analogues and nevirapine for previously untreated HIV-1 Infection: the OzCombo 2 study.
HIV Clin Trials. 2002 May-Jun; 3(3):177-85.HC

Abstract

PURPOSE

To assess and compare the efficacy and safety of three triple combination antiretroviral therapies in HIV-1-infected treatment-naive patients.

METHOD

Seventy treatment-naive HIV-infected adults with CD4+ T-cell counts >50/microL were randomized to receive either zidovudine + lamivudine + nevirapine (AZT + 3TC + NVP), stavudine + didanosine + nevirapine (d4T+ddI+NVP), or stavudine + lamivudine + nevirapine (d4T+3TC+NVP) for 52 weeks. Patient assessments were conducted monthly and included measurement of plasma HIV RNA levels and CD4+ T-cell counts and evaluations for drug toxicity.

RESULTS

The mean time-weighted reductions in plasma HIV RNA in the AZT+3TC+NVP, d4T+3TC+NVP, and d4T+ddI+NVP groups were 1.29, 2.13, and 1.78 log(10) copies/mL, respectively (p =.389). The proportions of patients with HIV RNA <50 copies/mL in the AZT+3TC+NVP, d4T+3TC+NVP, and d4T+ddI+NVP groups were 73%, 68%, and 80%, respectively (p =.71). The mean time-weighted increases in CD4+ T-cell counts in the AZT+3TC+NVP, d4T+3TC+NVP, and d4T+ddI+NVP groups were 139, 113, and 174 cells/microL, respectively (p =.30). Three patients ceased assigned treatment due to rash (one from each treatment arm), and 5 of the 45 patients on d4T (3 from the d4T+3TC+NVP arm and 2 from the d4T+ddI+NVP arm) ceased assigned treatment due to neuropathy.

CONCLUSION

All three-drug combinations were equally effective at suppressing viral load and increasing CD4+ T-cell counts. No significant differences were detected between the treatment groups in virological or immunological response or cessation of study drugs due to adverse events, although it is possible that the study was underpowered to detect differences. NVP was safe and efficacious in this setting, and efficacy was not influenced by nucleoside reverse transcriptase inhibitor backbone.

Authors+Show Affiliations

Department of Clinical Immunology and Biochemical Genetics, Royal Perth Hospital, Perth, WA, Australia. martyn.french@health.wa.gov.auNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

12032876

Citation

French, Martyn, et al. "Randomized, Open-label, Comparative Trial to Evaluate the Efficacy and Safety of Three Antiretroviral Drug Combinations Including Two Nucleoside Analogues and Nevirapine for Previously Untreated HIV-1 Infection: the OzCombo 2 Study." HIV Clinical Trials, vol. 3, no. 3, 2002, pp. 177-85.
French M, Amin J, Roth N, et al. Randomized, open-label, comparative trial to evaluate the efficacy and safety of three antiretroviral drug combinations including two nucleoside analogues and nevirapine for previously untreated HIV-1 Infection: the OzCombo 2 study. HIV Clin Trials. 2002;3(3):177-85.
French, M., Amin, J., Roth, N., Carr, A., Law, M., Emery, S., Drummond, F., & Cooper, D. (2002). Randomized, open-label, comparative trial to evaluate the efficacy and safety of three antiretroviral drug combinations including two nucleoside analogues and nevirapine for previously untreated HIV-1 Infection: the OzCombo 2 study. HIV Clinical Trials, 3(3), 177-85.
French M, et al. Randomized, Open-label, Comparative Trial to Evaluate the Efficacy and Safety of Three Antiretroviral Drug Combinations Including Two Nucleoside Analogues and Nevirapine for Previously Untreated HIV-1 Infection: the OzCombo 2 Study. HIV Clin Trials. 2002 May-Jun;3(3):177-85. PubMed PMID: 12032876.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomized, open-label, comparative trial to evaluate the efficacy and safety of three antiretroviral drug combinations including two nucleoside analogues and nevirapine for previously untreated HIV-1 Infection: the OzCombo 2 study. AU - French,Martyn, AU - Amin,Janaki, AU - Roth,Norman, AU - Carr,Andrew, AU - Law,Matthew, AU - Emery,Sean, AU - Drummond,Fraser, AU - Cooper,David, AU - ,, PY - 2002/5/29/pubmed PY - 2002/9/20/medline PY - 2002/5/29/entrez SP - 177 EP - 85 JF - HIV clinical trials JO - HIV Clin Trials VL - 3 IS - 3 N2 - PURPOSE: To assess and compare the efficacy and safety of three triple combination antiretroviral therapies in HIV-1-infected treatment-naive patients. METHOD: Seventy treatment-naive HIV-infected adults with CD4+ T-cell counts >50/microL were randomized to receive either zidovudine + lamivudine + nevirapine (AZT + 3TC + NVP), stavudine + didanosine + nevirapine (d4T+ddI+NVP), or stavudine + lamivudine + nevirapine (d4T+3TC+NVP) for 52 weeks. Patient assessments were conducted monthly and included measurement of plasma HIV RNA levels and CD4+ T-cell counts and evaluations for drug toxicity. RESULTS: The mean time-weighted reductions in plasma HIV RNA in the AZT+3TC+NVP, d4T+3TC+NVP, and d4T+ddI+NVP groups were 1.29, 2.13, and 1.78 log(10) copies/mL, respectively (p =.389). The proportions of patients with HIV RNA <50 copies/mL in the AZT+3TC+NVP, d4T+3TC+NVP, and d4T+ddI+NVP groups were 73%, 68%, and 80%, respectively (p =.71). The mean time-weighted increases in CD4+ T-cell counts in the AZT+3TC+NVP, d4T+3TC+NVP, and d4T+ddI+NVP groups were 139, 113, and 174 cells/microL, respectively (p =.30). Three patients ceased assigned treatment due to rash (one from each treatment arm), and 5 of the 45 patients on d4T (3 from the d4T+3TC+NVP arm and 2 from the d4T+ddI+NVP arm) ceased assigned treatment due to neuropathy. CONCLUSION: All three-drug combinations were equally effective at suppressing viral load and increasing CD4+ T-cell counts. No significant differences were detected between the treatment groups in virological or immunological response or cessation of study drugs due to adverse events, although it is possible that the study was underpowered to detect differences. NVP was safe and efficacious in this setting, and efficacy was not influenced by nucleoside reverse transcriptase inhibitor backbone. SN - 1528-4336 UR - https://www.unboundmedicine.com/medline/citation/12032876/Randomized_open_label_comparative_trial_to_evaluate_the_efficacy_and_safety_of_three_antiretroviral_drug_combinations_including_two_nucleoside_analogues_and_nevirapine_for_previously_untreated_HIV_1_Infection:_the_OzCombo_2_study_ L2 - http://www.tandfonline.com/doi/full/10.1310/9n21-1hg1-7n1q-jkw1 DB - PRIME DP - Unbound Medicine ER -