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
Jose M MiróAdvanz Study Group

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 ar...Continue Reading

References

Jul 27, 2001·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Q LengZ Bentwich
Apr 16, 2003·Annals of Internal Medicine·Frank J PalellaUNKNOWN HIV Outpatient Study Investigators
Sep 28, 2007·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Alessandro Soria, Adriano Lazzarin
Sep 28, 2007·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Enrico GirardiAntonella D'Arminio Monforte
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May 16, 2008·The New England Journal of Medicine·Sharon A RiddlerUNKNOWN AIDS Clinical Trials Group Study A5142 Team
Aug 5, 2008·JAMA : the Journal of the American Medical Association·Scott M HammerUNKNOWN International AIDS Society-USA
Jan 22, 2010·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Juan Sierra-MaderoJulio Montaner

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Citations

Aug 6, 2015·AIDS·Maria CasadellàUNKNOWN ADVANZ and ADVANZ-3 Investigators
Nov 7, 2015·AIDS·Marta BoffitoJosé M Gatell
Sep 29, 2020·PloS One·Aracele Tenório de Almeida E CavalcantiDemócrito de Barros Miranda-Filho

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Methods Mentioned

BETA
flow cytometry
Assay
genotyping

Software Mentioned

CELLQUEST
Stata

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