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Immune reconstitution in severely immunosuppressed antiretroviral-naive HIV type 1-infected patients using a nonnucleoside reverse transcriptase inhibitor-based or a boosted protease inhibitor-based antiretroviral regimen: three-year results (The Advanz Trial): a randomized, controlled trial.
AIDS Res Hum Retroviruses. 2010 Jul; 26(7):747-57.AR

Abstract

Late diagnosis of HIV-1 infection is quite frequent in Western countries. Very few randomized clinical trials to determine the best antiretroviral treatment in patients with advanced HIV-1 infection have been performed. To compare immune reconstitution in two groups of very immunosuppressed (less than 100 CD4(+) cells/microl), antiretroviral-naive HIV-1-infected adults, 65 patients were randomly assigned in a 1:1 ratio to receive zidovudine + lamivudine + efavirenz (group A, 34 patients) or zidovudine + lamivudine + ritonavir-boosted indinavir (group B, 31 patients). The median (interquartile range) CD4(+) cell increase after 12 and 36 months was +199 (101, 258) and +299 (170, 464) cells/microl in the efavirenz arm and +136 (57, 235) and +228 (119, 465) cells/microl in the ritonavir-boosted indinavir arm (p > 0.05 for all time points). The proportion (95% confidence interval) of patients achieving HIV-1 RNA levels under 50 copies/ml was significantly greater in the efavirenz arm at 3 years by the intention-to-treat analysis [59% (41%, 75%) vs. 23% (10%, 41%)], whereas no differences were found in the on-treatment analysis. Immune activation (CD8(+)CD38(+) and CD8(+)CD38DR(+) T cells) was significantly lower for the efavirenz arm from month 6 to month 24. Adverse events were more frequent in the ritonavir-boosted indinavir arm. Almost all cases of disease progression and death were observed in the first year of treatment, with no significant differences between the two arms (p = 0.79 by the log-rank test). At 1 and 3 years, the immune reconstitution induced by an efavirenz-based regimen in very immunosuppressed patients was at least as potent as that induced by a ritonavir-boosted protease inhibitor-based antiretroviral regimen.

Authors+Show Affiliations

Hospital Clínic-IDIBAPS, University of Barcelona, Barcelona, Spain. jmmiro@ub.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo 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)

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

Language

eng

PubMed ID

20624069

Citation

Miró, José M., et al. "Immune Reconstitution in Severely Immunosuppressed Antiretroviral-naive HIV Type 1-infected Patients Using a Nonnucleoside Reverse Transcriptase Inhibitor-based or a Boosted Protease Inhibitor-based Antiretroviral Regimen: Three-year Results (The Advanz Trial): a Randomized, Controlled Trial." AIDS Research and Human Retroviruses, vol. 26, no. 7, 2010, pp. 747-57.
Miró JM, Manzardo C, Pich J, et al. Immune reconstitution in severely immunosuppressed antiretroviral-naive HIV type 1-infected patients using a nonnucleoside reverse transcriptase inhibitor-based or a boosted protease inhibitor-based antiretroviral regimen: three-year results (The Advanz Trial): a randomized, controlled trial. AIDS Res Hum Retroviruses. 2010;26(7):747-57.
Miró, J. M., Manzardo, C., Pich, J., Domingo, P., Ferrer, E., Arribas, J. R., Ribera, E., Arrizabalaga, J., Loncá, M., Cruceta, A., de Lazzari, E., Fuster, M., Podzamczer, D., Plana, M., & Gatell, J. M. (2010). Immune reconstitution in severely immunosuppressed antiretroviral-naive HIV type 1-infected patients using a nonnucleoside reverse transcriptase inhibitor-based or a boosted protease inhibitor-based antiretroviral regimen: three-year results (The Advanz Trial): a randomized, controlled trial. AIDS Research and Human Retroviruses, 26(7), 747-57. https://doi.org/10.1089/aid.2009.0105
Miró JM, et al. Immune Reconstitution in Severely Immunosuppressed Antiretroviral-naive HIV Type 1-infected Patients Using a Nonnucleoside Reverse Transcriptase Inhibitor-based or a Boosted Protease Inhibitor-based Antiretroviral Regimen: Three-year Results (The Advanz Trial): a Randomized, Controlled Trial. AIDS Res Hum Retroviruses. 2010;26(7):747-57. PubMed PMID: 20624069.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Immune reconstitution in severely immunosuppressed antiretroviral-naive HIV type 1-infected patients using a nonnucleoside reverse transcriptase inhibitor-based or a boosted protease inhibitor-based antiretroviral regimen: three-year results (The Advanz Trial): a randomized, controlled trial. AU - Miró,José M, AU - Manzardo,Christian, AU - Pich,Judith, AU - Domingo,Pere, AU - Ferrer,Elena, AU - Arribas,José R, AU - Ribera,Esteban, AU - Arrizabalaga,Julio, AU - Loncá,Montserrat, AU - Cruceta,Anna, AU - de Lazzari,Elisa, AU - Fuster,Montserrat, AU - Podzamczer,Daniel, AU - Plana,Montserrat, AU - Gatell,José M, AU - ,, PY - 2010/7/14/entrez PY - 2010/7/14/pubmed PY - 2010/10/20/medline SP - 747 EP - 57 JF - AIDS research and human retroviruses JO - AIDS Res Hum Retroviruses VL - 26 IS - 7 N2 - Late diagnosis of HIV-1 infection is quite frequent in Western countries. Very few randomized clinical trials to determine the best antiretroviral treatment in patients with advanced HIV-1 infection have been performed. To compare immune reconstitution in two groups of very immunosuppressed (less than 100 CD4(+) cells/microl), antiretroviral-naive HIV-1-infected adults, 65 patients were randomly assigned in a 1:1 ratio to receive zidovudine + lamivudine + efavirenz (group A, 34 patients) or zidovudine + lamivudine + ritonavir-boosted indinavir (group B, 31 patients). The median (interquartile range) CD4(+) cell increase after 12 and 36 months was +199 (101, 258) and +299 (170, 464) cells/microl in the efavirenz arm and +136 (57, 235) and +228 (119, 465) cells/microl in the ritonavir-boosted indinavir arm (p > 0.05 for all time points). The proportion (95% confidence interval) of patients achieving HIV-1 RNA levels under 50 copies/ml was significantly greater in the efavirenz arm at 3 years by the intention-to-treat analysis [59% (41%, 75%) vs. 23% (10%, 41%)], whereas no differences were found in the on-treatment analysis. Immune activation (CD8(+)CD38(+) and CD8(+)CD38DR(+) T cells) was significantly lower for the efavirenz arm from month 6 to month 24. Adverse events were more frequent in the ritonavir-boosted indinavir arm. Almost all cases of disease progression and death were observed in the first year of treatment, with no significant differences between the two arms (p = 0.79 by the log-rank test). At 1 and 3 years, the immune reconstitution induced by an efavirenz-based regimen in very immunosuppressed patients was at least as potent as that induced by a ritonavir-boosted protease inhibitor-based antiretroviral regimen. SN - 1931-8405 UR - https://www.unboundmedicine.com/medline/citation/20624069/Immune_reconstitution_in_severely_immunosuppressed_antiretroviral_naive_HIV_type_1_infected_patients_using_a_nonnucleoside_reverse_transcriptase_inhibitor_based_or_a_boosted_protease_inhibitor_based_antiretroviral_regimen:_three_year_results__The_Advanz_Trial_:_a_randomized_controlled_trial_ L2 - https://www.liebertpub.com/doi/10.1089/aid.2009.0105?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -