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A Randomized Comparison of Anthropomorphic Changes With Preferred and Alternative Efavirenz-Based Antiretroviral Regimens in Diverse Multinational Settings

Background. Existing data on anthropomorphic changes in resource-limited settings primarily come from observational or cross-sectional studies. Data from randomized clinical trials are needed to inform treatment decisions in these areas of the world. Methods. The AIDS Clinical Trials Group Prospecti...

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Autores principales: Erlandson, Kristine M., Taejaroenkul, Sineenart, Smeaton, Laura, Gupta, Amita, Singini, Isaac L., Lama, Javier R., Mngqibisa, Rosie, Firnhaber, Cynthia, Cardoso, Sandra Wagner, Kanyama, Cecilia, Machado da Silva, Andre L., Hakim, James G., Kumarasamy, Nagalingeswaran, Campbell, Thomas B., Hughes, Michael D.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4512142/
https://www.ncbi.nlm.nih.gov/pubmed/26213694
http://dx.doi.org/10.1093/ofid/ofv095
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author Erlandson, Kristine M.
Taejaroenkul, Sineenart
Smeaton, Laura
Gupta, Amita
Singini, Isaac L.
Lama, Javier R.
Mngqibisa, Rosie
Firnhaber, Cynthia
Cardoso, Sandra Wagner
Kanyama, Cecilia
Machado da Silva, Andre L.
Hakim, James G.
Kumarasamy, Nagalingeswaran
Campbell, Thomas B.
Hughes, Michael D.
author_facet Erlandson, Kristine M.
Taejaroenkul, Sineenart
Smeaton, Laura
Gupta, Amita
Singini, Isaac L.
Lama, Javier R.
Mngqibisa, Rosie
Firnhaber, Cynthia
Cardoso, Sandra Wagner
Kanyama, Cecilia
Machado da Silva, Andre L.
Hakim, James G.
Kumarasamy, Nagalingeswaran
Campbell, Thomas B.
Hughes, Michael D.
author_sort Erlandson, Kristine M.
collection PubMed
description Background. Existing data on anthropomorphic changes in resource-limited settings primarily come from observational or cross-sectional studies. Data from randomized clinical trials are needed to inform treatment decisions in these areas of the world. Methods. The AIDS Clinical Trials Group Prospective Evaluation of Antiretrovirals in Resource-Limited Settings (PEARLS) study was a prospective, randomized evaluation of the efficacy of emtricitabine/tenofovir + efavirenz (FTC/TDF + EFV) vs lamivudine/zidovudine + efavirenz (3TC/ZDV + EFV) for the initial treatment of human immunodeficiency virus (HIV)-1-infected individuals from resource-diverse settings. Changes in anthropomorphic measures were analyzed using mixed-effect models for repeated measurements, using all available measurements at weeks 48, 96, and 144. Intent-to-treat results are presented; as-treated results were similar. Results. Five hundred twenty-six participants were randomized to FTC/TDF + EFV, and 519 participants were randomized to 3TC/ZDV + EFV. Significantly greater increases from baseline to week 144 were seen among those randomized to FTC/TDF + EFV vs 3TC/ZDV + EFV in all measures except waist-to-hip ratio, with the following mean changes: weight, 4.8 vs 3.0 kg; body mass index, 1.8 vs 1.1 kg/m(2); mid-arm, 1.7 vs 0.7 cm; waist, 5.2 vs 4.3 cm; hip, 3.8 vs 1.4 cm; and mid-thigh circumference, 3.1 vs 0.9 cm. There were 7 clinical diagnoses of lipoatrophy in the 3TC/ZDV + EFV arm compared with none in the FTC/TDF + EFV arm. The proportion of overweight or obese participants increased from 25% (week 0) to 42% (week 144) for FTC/TDF + EFV and from 26% to 38% for 3TC/ZDV + EFV. Conclusions. Our findings support first-line use of FTC/TDF + EFV in resource-limited settings and emphasize the need for interventions to limit weight gain among overweight or obese HIV-infected participants in all settings.
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spelling pubmed-45121422015-07-24 A Randomized Comparison of Anthropomorphic Changes With Preferred and Alternative Efavirenz-Based Antiretroviral Regimens in Diverse Multinational Settings Erlandson, Kristine M. Taejaroenkul, Sineenart Smeaton, Laura Gupta, Amita Singini, Isaac L. Lama, Javier R. Mngqibisa, Rosie Firnhaber, Cynthia Cardoso, Sandra Wagner Kanyama, Cecilia Machado da Silva, Andre L. Hakim, James G. Kumarasamy, Nagalingeswaran Campbell, Thomas B. Hughes, Michael D. Open Forum Infect Dis Major Articles Background. Existing data on anthropomorphic changes in resource-limited settings primarily come from observational or cross-sectional studies. Data from randomized clinical trials are needed to inform treatment decisions in these areas of the world. Methods. The AIDS Clinical Trials Group Prospective Evaluation of Antiretrovirals in Resource-Limited Settings (PEARLS) study was a prospective, randomized evaluation of the efficacy of emtricitabine/tenofovir + efavirenz (FTC/TDF + EFV) vs lamivudine/zidovudine + efavirenz (3TC/ZDV + EFV) for the initial treatment of human immunodeficiency virus (HIV)-1-infected individuals from resource-diverse settings. Changes in anthropomorphic measures were analyzed using mixed-effect models for repeated measurements, using all available measurements at weeks 48, 96, and 144. Intent-to-treat results are presented; as-treated results were similar. Results. Five hundred twenty-six participants were randomized to FTC/TDF + EFV, and 519 participants were randomized to 3TC/ZDV + EFV. Significantly greater increases from baseline to week 144 were seen among those randomized to FTC/TDF + EFV vs 3TC/ZDV + EFV in all measures except waist-to-hip ratio, with the following mean changes: weight, 4.8 vs 3.0 kg; body mass index, 1.8 vs 1.1 kg/m(2); mid-arm, 1.7 vs 0.7 cm; waist, 5.2 vs 4.3 cm; hip, 3.8 vs 1.4 cm; and mid-thigh circumference, 3.1 vs 0.9 cm. There were 7 clinical diagnoses of lipoatrophy in the 3TC/ZDV + EFV arm compared with none in the FTC/TDF + EFV arm. The proportion of overweight or obese participants increased from 25% (week 0) to 42% (week 144) for FTC/TDF + EFV and from 26% to 38% for 3TC/ZDV + EFV. Conclusions. Our findings support first-line use of FTC/TDF + EFV in resource-limited settings and emphasize the need for interventions to limit weight gain among overweight or obese HIV-infected participants in all settings. Oxford University Press 2015-06-24 /pmc/articles/PMC4512142/ /pubmed/26213694 http://dx.doi.org/10.1093/ofid/ofv095 Text en © The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com.
spellingShingle Major Articles
Erlandson, Kristine M.
Taejaroenkul, Sineenart
Smeaton, Laura
Gupta, Amita
Singini, Isaac L.
Lama, Javier R.
Mngqibisa, Rosie
Firnhaber, Cynthia
Cardoso, Sandra Wagner
Kanyama, Cecilia
Machado da Silva, Andre L.
Hakim, James G.
Kumarasamy, Nagalingeswaran
Campbell, Thomas B.
Hughes, Michael D.
A Randomized Comparison of Anthropomorphic Changes With Preferred and Alternative Efavirenz-Based Antiretroviral Regimens in Diverse Multinational Settings
title A Randomized Comparison of Anthropomorphic Changes With Preferred and Alternative Efavirenz-Based Antiretroviral Regimens in Diverse Multinational Settings
title_full A Randomized Comparison of Anthropomorphic Changes With Preferred and Alternative Efavirenz-Based Antiretroviral Regimens in Diverse Multinational Settings
title_fullStr A Randomized Comparison of Anthropomorphic Changes With Preferred and Alternative Efavirenz-Based Antiretroviral Regimens in Diverse Multinational Settings
title_full_unstemmed A Randomized Comparison of Anthropomorphic Changes With Preferred and Alternative Efavirenz-Based Antiretroviral Regimens in Diverse Multinational Settings
title_short A Randomized Comparison of Anthropomorphic Changes With Preferred and Alternative Efavirenz-Based Antiretroviral Regimens in Diverse Multinational Settings
title_sort randomized comparison of anthropomorphic changes with preferred and alternative efavirenz-based antiretroviral regimens in diverse multinational settings
topic Major Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4512142/
https://www.ncbi.nlm.nih.gov/pubmed/26213694
http://dx.doi.org/10.1093/ofid/ofv095
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