Evidence map›Paper›PMID 22661489›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2012

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 and 19 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00096824 (International Neurological Study), which is not on this map. Cited by 50 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
50citing papers in PubMed, 3 pooled it
2.5field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00096824 completednot on this map

International Neurological Study: A Stand Alone Study for Participants of A5175 (A Phase IV, Randomized, Open-Label Evaluation of the Efficacy of Once-Daily Protease Inhibitor and Once-Daily Non-Nucleoside Reverse Transcriptase Inhibitor-Containing Therapy Combination for Initial Treatment of HIV-1 Infected Individuals From Diverse Areas of the World)

TypeobservationalSponsorAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other InfectionsRan2006 to 2010Enrolled860ConditionsHIV InfectionsArmsNeurological assessment
3 · Its place in the literature

Who cites it

50 citing papers in PubMed, 3 syntheses or guidelines pooled it, 61 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Antiretroviral Therapy Intensification for Neurocognitive Impairment in Human Immunodeficiency Virus.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023
    Trial
  5. Trial
  6. Trial
  7. Article
  8. Observational
  9. Article
  10. Article
  11. Article
  12. Glutathione in HIV-Associated Neurocognitive Disorders.Current issues in molecular biology · 2024
    Review
  13. Review
  14. Article
  15. Review
  16. Beneficial and Adverse Effects of cART Affect Neurocognitive Function in HIV-1 Infection: Balancing Viral Suppression against Neuronal Stress and Injury.Journal of neuroimmune pharmacology : the official journal of the Society on NeuroImmune Pharmacology · 2021
    Review
  17. Neurocognitive Complications of HIV Infection in Low-Income Countries.Current topics in behavioral neurosciences · 2021
    Article
  18. Article
  19. Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

29 authors at 16 institutions in 8 countries.

K RobertsonUniversity of North Carolina, Chapel Hill, 27599-7025, USA. kevinr@neurology.unc.edu
H Jiang
J Kumwenda
K Supparatpinyo
S Evans
T B Campbell
R Price
S Tripathy
N Kumarasamy
A La Rosa
B Santos
5199 study team
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
AIDS Clinical Trials Group
Northwestern University · USAsociación Civil Impacta Salud y Educación · PEKamuzu Central Hospital · MWUniversity of North Carolina at Chapel Hill · USFrontier Science & Technology Research Foundation · USHarvard University Press · USUniversity of Zimbabwe · ZWChiang Mai University · THFundação Oswaldo Cruz · BRHelen Joseph Hospital · ZAHospital Nossa Senhora da Conceição · BRNational AIDS Research Institute · INQueen Elizabeth Central Hospital · MWUniversity of California, San Francisco · USUniversity of Colorado Denver · USYR Gaitonde Centre for AIDS Research and Education · IN

Funding

Statistical and Data Management Center (SDMC), AIDS Clinical Trials Group (ACTG)UM1AI068634 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Marlene Ann Cooper, Michael David Hughes · 2011 to 2026
$246.6M
AIDS Clinical Trials Group NetworkU01AI068636 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI KURITZKES, DANIEL R. · 2006 to 2010
$147.1M
Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
Statistical and Data Management Center for the AIDS Clinical Trials GroupU01AI068634 · NIAID · HARVARD SCHOOL OF PUBLIC HEALTH · PI HUGHES, MICHAEL DAVID · 2006 to 2010
$71.9M
UCSD Department of Medicine HIV/AIDS Clinical Trials UnitUM1AI069432 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI TIMOTHY J. WILKIN · 2012 to 2026
$50.4M
The Malawi Clinical Trials UnitU01AI069518 · NIAID · JOHNS HOPKINS UNIVERSITY · PI TAHA, TAHA E · 2007 to 2011
$46.7M
The Malawi Clinical Trials UnitUM1AI069518 · NIAID · JOHNS HOPKINS UNIVERSITY · PI JACKY M JENNINGS, TAHA E TAHA · 2012 to 2026
$43.8M
THE IMPACTA PERU CLINICAL TRIALS UNITUM1AI069438 · NIAID · ASOCIACION CIVIL IMPACTA SALUD Y EDUCACN · PI Alberto La Rosa, Jorge Luis Sanchez · 2012 to 2026
$43.2M
Wits HIV Research Group CLINICAL TRIAL UNIT (CTU) reapplicationUM1AI069463 · NIAID · WITS HEALTH CONSORTIUM (PTY), LTD · PI REES, HELEN, SANNE, IAN MATTHIAS · 2012 to 2025
$31.8M
The FIOCRUZ Therapeutic and Prevention HIV/AIDS Clinical Trials Unit (FioTrials)UM1AI069476 · NIAID · FUNDACAO OSWALDO CRUZ · PI BEATRIZ GRINSZTEJN · 2012 to 2026
$26.3M
Thailand HIV/AIDS and Infectious Disease Clinical Trials Unit (THAI CTU)UM1AI069399 · NIAID · CHIANG MAI UNIVERSITY · PI Kiat Ruxrungtham, Khuanchai Supparatpinyo · 2012 to 2026
$25.0M
Units for HIV/AIDS Clinical Trials NetworksU01AI069463 · NIAID · WITS HEALTH CONSORTIUM (PTY), LTD · PI SANNE, IAN MATTHIAS · 2007 to 2011
$24.2M
NIAID NIH HHS 5 U01AI069401NIAID NIH HHS 5U01AI069417-03NIAID NIH HHS 5U01AI069426-03NIAID NIH HHS 5U01 AI069438-03NIAID NIH HHS AI-068634NIAID NIH HHS AI069399NIAID NIH HHS AI069432NIAID NIH HHS AI069450NIAID NIH HHS AI069518NIAID NIH HHS AI69476NIAID NIH HHS P30 AI050410NIAID NIH HHS U01 AI068634NIAID NIH HHS U01 AI068636NIAID NIH HHS U01AI068636NIAID NIH HHS U01 AI069399NIAID NIH HHS U01 AI069401NIAID NIH HHS U01 AI069417NIAID NIH HHS U01 AI069426NIAID NIH HHS U01 AI069432NIAID NIH HHS U01 AI069438NIAID NIH HHS U01 AI069450NIAID NIH HHS U01 AI069463NIAID NIH HHS U01 AI069476NIAID NIH HHS U01 AI069518NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI069399NIAID NIH HHS UM1 AI069432NIAID NIH HHS UM1 AI069438NIAID NIH HHS UM1 AI069450NIAID NIH HHS UM1 AI069463NIAID NIH HHS UM1 AI069476NIAID NIH HHS UM1 AI069518
6 · The paper itself

Abstract

backgroundAIDS 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.

methodsParticipants 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.

resultsThe 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).

conclusionsThe 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. CLINICAL TRIALS REGISTRATION: NCT00096824.

Indexed as

Acquired Immunodeficiency SyndromeAdultAIDS Dementia ComplexAnti-Retroviral AgentsAntiretroviral Therapy, Highly ActiveFemaleHIV-1HumansMaleNeurologic ExaminationPsychological TestsTreatment OutcomeAnti-Retroviral Agents

Identifiers

PMID22661489
PMCPMC3491853
OpenAlexW2169248326

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.