Improved neuropsychological and neurological functioning across three antiretroviral regimens in diverse resource-limited settings: Aids clinical trials group study A5199, the international neurological study

K. Robertson; H. Jiang; J. Kumwenda; K. Supparatpinyo; S. Evans; T. B. Campbell; R. Price; S. Tripathy; N. Kumarasamy; A. La Rosa; B. Santos; M. T. Silva; S. Montano; C. Kanyama; S. Faesen; R. Murphy; C. Hall; C. M. Marra; C. Marcus; B. Berzins; R. Allen; M. Housseinipour; F. Amod; I. Sanne; J. Hakim; A. Walawander; A. Nair

doi:10.1093/cid/cis507

Improved neuropsychological and neurological functioning across three antiretroviral regimens in diverse resource-limited settings: Aids clinical trials group study A5199, the international neurological study

K. Robertson^*, H. Jiang, J. Kumwenda, K. Supparatpinyo, S. Evans, T. B. Campbell, R. Price, S. Tripathy, N. Kumarasamy, A. La Rosa, B. Santos, M. T. Silva, S. Montano, C. Kanyama, S. Faesen, R. Murphy, C. Hall, C. M. Marra, C. Marcus, B. BerzinsR. Allen, M. Housseinipour, F. Amod, I. Sanne, J. Hakim, A. Walawander, A. Nair

^*Corresponding author for this work

Medicine, Infectious Diseases Division

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Abstract

Background. AIDS Clinical Trials Group (ACTG) A5199 compared the neurological and neuropsychological (NP) effects of 3 antiretroviral regimens in participants infected with human immunodeficiency virus type 1 (HIV-1) in resource-limited settings.Methods.Participants from Brazil, India, Malawi, Peru, South Africa, Thailand, and Zimbabwe were randomized to 3 antiretroviral treatment arms: A (lamivudine-zidovudine plus efavirenz, n = 289), B (atazanavir, emtricitabine, and didanosine-EC, n = 293), and C (emtricitabine-tenofovir-disoproxil fumarate plus efavirenz, n = 278) as part of the ACTG PEARLS study (A5175). Standardized neurological and neuropsychological (NP) screening examinations (grooved pegboard, timed gait, semantic verbal fluency, and finger tapping) were administered every 24 weeks from February 2006 to May 2010. Associations with neurological and neuropsychological function were estimated from linear and logistic regression models using generalized estimating equations.Results.The median weeks on study was 168 (Q1 = 96, Q3 = 192) for the 860 participants. NP test scores improved (P <. 05) with the exception of semantic verbal fluency. No differences in neurological and neuropsychological functioning between treatment regimens were detected (P >. 10). Significant country effects were noted on all NP tests and neurological outcomes (P <. 01).Conclusions.The study detected no significant differences in neuropsychological and neurological outcomes between randomized ART regimens. Significant improvement occurred in neurocognitive and neurological functioning over time after initiation of ARTs. The etiology of these improvements is likely multifactorial, reflecting reduced central nervous system HIV infection, better general health, and practice effects. This study suggests that treatment with either of the World Health Organization-recommended first-line antiretroviral regimens in resource-limited settings will improve neuropsychological functioning and reduce neurological dysfunction.

Original language	English (US)
Pages (from-to)	868-876
Number of pages	9
Journal	Clinical Infectious Diseases
Volume	55
Issue number	6
DOIs	https://doi.org/10.1093/cid/cis507
State	Published - Sep 2012

Funding

Dr Raman Gnagakhedkar and Usha Katti, MBBS—Dr Kotnis Dispensary, NARI (Site 11602) CTU grant number 5U01AI069417-03. Thomas Campbell, MD, grant support from NIAID ACTU AI069450. Dr Scott R Evans and Hongyu Jiang were funded in part by the Statistical and Data Management Center of the Adult AIDS Clinical Trials Group grant 1 U01 068634. Financial support. The project described was supported by the National Institute of Mental Health, and the AIDS Clinical Trials Group (ACTG) funded by The NIAID Award number U01AI068636, General Clinical Research Center (GCRC) funded by the National Center for Research Resources, and Statistical and Data Analysis Center (SDAC) grant number AI-068634. C. M., R. A., K. S., A. L. R., B. B., B. S., C. M., C. H., R. W. P., S. T., J. H., and I. S. received NIH grant support from ACTG U01AI068636. Virginia M. Kayoyo and Franklin D. Kilembe, MPh—Franklin Kilembe University of North Carolina Project, Kamuzu Central Hospital, Lilongwe (Site 12001) CTU grant number AI069518.

ASJC Scopus subject areas

Microbiology (medical)
Infectious Diseases

UN SDGs

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Robertson, K., Jiang, H., Kumwenda, J., Supparatpinyo, K., Evans, S., Campbell, T. B., Price, R., Tripathy, S., Kumarasamy, N., La Rosa, A., Santos, B., Silva, M. T., Montano, S., Kanyama, C., Faesen, S., Murphy, R., Hall, C., Marra, C. M., Marcus, C., ... Nair, A. (2012). Improved neuropsychological and neurological functioning across three antiretroviral regimens in diverse resource-limited settings: Aids clinical trials group study A5199, the international neurological study. Clinical Infectious Diseases, 55(6), 868-876. https://doi.org/10.1093/cid/cis507

@article{912d4d21937b4ab9a78141f5963fe4f4,

title = "Improved neuropsychological and neurological functioning across three antiretroviral regimens in diverse resource-limited settings: Aids clinical trials group study A5199, the international neurological study",

abstract = "Background. AIDS Clinical Trials Group (ACTG) A5199 compared the neurological and neuropsychological (NP) effects of 3 antiretroviral regimens in participants infected with human immunodeficiency virus type 1 (HIV-1) in resource-limited settings.Methods.Participants from Brazil, India, Malawi, Peru, South Africa, Thailand, and Zimbabwe were randomized to 3 antiretroviral treatment arms: A (lamivudine-zidovudine plus efavirenz, n = 289), B (atazanavir, emtricitabine, and didanosine-EC, n = 293), and C (emtricitabine-tenofovir-disoproxil fumarate plus efavirenz, n = 278) as part of the ACTG PEARLS study (A5175). Standardized neurological and neuropsychological (NP) screening examinations (grooved pegboard, timed gait, semantic verbal fluency, and finger tapping) were administered every 24 weeks from February 2006 to May 2010. Associations with neurological and neuropsychological function were estimated from linear and logistic regression models using generalized estimating equations.Results.The median weeks on study was 168 (Q1 = 96, Q3 = 192) for the 860 participants. NP test scores improved (P <. 05) with the exception of semantic verbal fluency. No differences in neurological and neuropsychological functioning between treatment regimens were detected (P >. 10). Significant country effects were noted on all NP tests and neurological outcomes (P <. 01).Conclusions.The study detected no significant differences in neuropsychological and neurological outcomes between randomized ART regimens. Significant improvement occurred in neurocognitive and neurological functioning over time after initiation of ARTs. The etiology of these improvements is likely multifactorial, reflecting reduced central nervous system HIV infection, better general health, and practice effects. This study suggests that treatment with either of the World Health Organization-recommended first-line antiretroviral regimens in resource-limited settings will improve neuropsychological functioning and reduce neurological dysfunction.",

author = "K. Robertson and H. Jiang and J. Kumwenda and K. Supparatpinyo and S. Evans and Campbell, {T. B.} and R. Price and S. Tripathy and N. Kumarasamy and {La Rosa}, A. and B. Santos and Silva, {M. T.} and S. Montano and C. Kanyama and S. Faesen and R. Murphy and C. Hall and Marra, {C. M.} and C. Marcus and B. Berzins and R. Allen and M. Housseinipour and F. Amod and I. Sanne and J. Hakim and A. Walawander and A. Nair",

note = "Funding Information: Dr Raman Gnagakhedkar and Usha Katti, MBBS—Dr Kotnis Dispensary, NARI (Site 11602) CTU grant number 5U01AI069417-03. Funding Information: Thomas Campbell, MD, grant support from NIAID ACTU AI069450. Funding Information: Dr Scott R Evans and Hongyu Jiang were funded in part by the Statistical and Data Management Center of the Adult AIDS Clinical Trials Group grant 1 U01 068634. Funding Information: Financial support. The project described was supported by the National Institute of Mental Health, and the AIDS Clinical Trials Group (ACTG) funded by The NIAID Award number U01AI068636, General Clinical Research Center (GCRC) funded by the National Center for Research Resources, and Statistical and Data Analysis Center (SDAC) grant number AI-068634. C. M., R. A., K. S., A. L. R., B. B., B. S., C. M., C. H., R. W. P., S. T., J. H., and I. S. received NIH grant support from ACTG U01AI068636. Funding Information: Virginia M. Kayoyo and Franklin D. Kilembe, MPh—Franklin Kilembe University of North Carolina Project, Kamuzu Central Hospital, Lilongwe (Site 12001) CTU grant number AI069518.",

year = "2012",

month = sep,

doi = "10.1093/cid/cis507",

language = "English (US)",

volume = "55",

pages = "868--876",

journal = "Clinical Infectious Diseases",

issn = "1058-4838",

publisher = "Oxford University Press",

number = "6",

}

Robertson, K, Jiang, H, Kumwenda, J, Supparatpinyo, K, Evans, S, Campbell, TB, Price, R, Tripathy, S, Kumarasamy, N, La Rosa, A, Santos, B, Silva, MT, Montano, S, Kanyama, C, Faesen, S, Murphy, R, Hall, C, Marra, CM, Marcus, C, Berzins, B, Allen, R, Housseinipour, M, Amod, F, Sanne, I, Hakim, J, Walawander, A & Nair, A 2012, 'Improved neuropsychological and neurological functioning across three antiretroviral regimens in diverse resource-limited settings: Aids clinical trials group study A5199, the international neurological study', Clinical Infectious Diseases, vol. 55, no. 6, pp. 868-876. https://doi.org/10.1093/cid/cis507

Improved neuropsychological and neurological functioning across three antiretroviral regimens in diverse resource-limited settings: Aids clinical trials group study A5199, the international neurological study. / Robertson, K.; Jiang, H.; Kumwenda, J. et al.
In: Clinical Infectious Diseases, Vol. 55, No. 6, 09.2012, p. 868-876.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Improved neuropsychological and neurological functioning across three antiretroviral regimens in diverse resource-limited settings

T2 - Aids clinical trials group study A5199, the international neurological study

AU - Robertson, K.

AU - Jiang, H.

AU - Kumwenda, J.

AU - Supparatpinyo, K.

AU - Evans, S.

AU - Campbell, T. B.

AU - Price, R.

AU - Tripathy, S.

AU - Kumarasamy, N.

AU - La Rosa, A.

AU - Santos, B.

AU - Silva, M. T.

AU - Montano, S.

AU - Kanyama, C.

AU - Faesen, S.

AU - Murphy, R.

AU - Hall, C.

AU - Marra, C. M.

AU - Marcus, C.

AU - Berzins, B.

AU - Allen, R.

AU - Housseinipour, M.

AU - Amod, F.

AU - Sanne, I.

AU - Hakim, J.

AU - Walawander, A.

AU - Nair, A.

N1 - Funding Information: Dr Raman Gnagakhedkar and Usha Katti, MBBS—Dr Kotnis Dispensary, NARI (Site 11602) CTU grant number 5U01AI069417-03. Funding Information: Thomas Campbell, MD, grant support from NIAID ACTU AI069450. Funding Information: Dr Scott R Evans and Hongyu Jiang were funded in part by the Statistical and Data Management Center of the Adult AIDS Clinical Trials Group grant 1 U01 068634. Funding Information: Financial support. The project described was supported by the National Institute of Mental Health, and the AIDS Clinical Trials Group (ACTG) funded by The NIAID Award number U01AI068636, General Clinical Research Center (GCRC) funded by the National Center for Research Resources, and Statistical and Data Analysis Center (SDAC) grant number AI-068634. C. M., R. A., K. S., A. L. R., B. B., B. S., C. M., C. H., R. W. P., S. T., J. H., and I. S. received NIH grant support from ACTG U01AI068636. Funding Information: Virginia M. Kayoyo and Franklin D. Kilembe, MPh—Franklin Kilembe University of North Carolina Project, Kamuzu Central Hospital, Lilongwe (Site 12001) CTU grant number AI069518.

PY - 2012/9

Y1 - 2012/9

N2 - Background. AIDS Clinical Trials Group (ACTG) A5199 compared the neurological and neuropsychological (NP) effects of 3 antiretroviral regimens in participants infected with human immunodeficiency virus type 1 (HIV-1) in resource-limited settings.Methods.Participants from Brazil, India, Malawi, Peru, South Africa, Thailand, and Zimbabwe were randomized to 3 antiretroviral treatment arms: A (lamivudine-zidovudine plus efavirenz, n = 289), B (atazanavir, emtricitabine, and didanosine-EC, n = 293), and C (emtricitabine-tenofovir-disoproxil fumarate plus efavirenz, n = 278) as part of the ACTG PEARLS study (A5175). Standardized neurological and neuropsychological (NP) screening examinations (grooved pegboard, timed gait, semantic verbal fluency, and finger tapping) were administered every 24 weeks from February 2006 to May 2010. Associations with neurological and neuropsychological function were estimated from linear and logistic regression models using generalized estimating equations.Results.The median weeks on study was 168 (Q1 = 96, Q3 = 192) for the 860 participants. NP test scores improved (P <. 05) with the exception of semantic verbal fluency. No differences in neurological and neuropsychological functioning between treatment regimens were detected (P >. 10). Significant country effects were noted on all NP tests and neurological outcomes (P <. 01).Conclusions.The study detected no significant differences in neuropsychological and neurological outcomes between randomized ART regimens. Significant improvement occurred in neurocognitive and neurological functioning over time after initiation of ARTs. The etiology of these improvements is likely multifactorial, reflecting reduced central nervous system HIV infection, better general health, and practice effects. This study suggests that treatment with either of the World Health Organization-recommended first-line antiretroviral regimens in resource-limited settings will improve neuropsychological functioning and reduce neurological dysfunction.

AB - Background. AIDS Clinical Trials Group (ACTG) A5199 compared the neurological and neuropsychological (NP) effects of 3 antiretroviral regimens in participants infected with human immunodeficiency virus type 1 (HIV-1) in resource-limited settings.Methods.Participants from Brazil, India, Malawi, Peru, South Africa, Thailand, and Zimbabwe were randomized to 3 antiretroviral treatment arms: A (lamivudine-zidovudine plus efavirenz, n = 289), B (atazanavir, emtricitabine, and didanosine-EC, n = 293), and C (emtricitabine-tenofovir-disoproxil fumarate plus efavirenz, n = 278) as part of the ACTG PEARLS study (A5175). Standardized neurological and neuropsychological (NP) screening examinations (grooved pegboard, timed gait, semantic verbal fluency, and finger tapping) were administered every 24 weeks from February 2006 to May 2010. Associations with neurological and neuropsychological function were estimated from linear and logistic regression models using generalized estimating equations.Results.The median weeks on study was 168 (Q1 = 96, Q3 = 192) for the 860 participants. NP test scores improved (P <. 05) with the exception of semantic verbal fluency. No differences in neurological and neuropsychological functioning between treatment regimens were detected (P >. 10). Significant country effects were noted on all NP tests and neurological outcomes (P <. 01).Conclusions.The study detected no significant differences in neuropsychological and neurological outcomes between randomized ART regimens. Significant improvement occurred in neurocognitive and neurological functioning over time after initiation of ARTs. The etiology of these improvements is likely multifactorial, reflecting reduced central nervous system HIV infection, better general health, and practice effects. This study suggests that treatment with either of the World Health Organization-recommended first-line antiretroviral regimens in resource-limited settings will improve neuropsychological functioning and reduce neurological dysfunction.

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Improved neuropsychological and neurological functioning across three antiretroviral regimens in diverse resource-limited settings: Aids clinical trials group study A5199, the international neurological study

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