학술논문

Improved Neuropsychological and Neurological Functioning Across Three Antiretroviral Regimens in Diverse Resource-Limited Settings: AIDS Clinical Trials Group Study A5199, the International Neurological Study
Document Type
article
Source
Clinical Infectious Diseases. 55(6)
Subject
Clinical Trials and Supportive Activities
Neurosciences
Mental Health
Infectious Diseases
HIV/AIDS
Clinical Research
Prevention
Behavioral and Social Science
6.1 Pharmaceuticals
Evaluation of treatments and therapeutic interventions
Infection
Good Health and Well Being
AIDS Dementia Complex
Acquired Immunodeficiency Syndrome
Adult
Anti-Retroviral Agents
Antiretroviral Therapy
Highly Active
Female
HIV-1
Humans
Male
Neurologic Examination
Psychological Tests
Treatment Outcome
study team
AIDS Clinical Trials Group
Biological Sciences
Medical and Health Sciences
Microbiology
Language
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 registrationNCT00096824.