Antiretroviral Therapy Intensification for Neurocognitive Impairment in Human Immunodeficiency Virus.
Clin Infect Dis
; 77(6): 866-874, 2023 09 18.
Article
en En
| MEDLINE
| ID: mdl-37183889
ABSTRACT
BACKGROUND:
Neurocognitive impairment (NCI) in people with HIV (PWH) on antiretroviral therapy (ART) is common and may result from persistent HIV replication in the central nervous system.METHODS:
A5324 was a randomized, double-blind, placebo-controlled, 96-week trial of ART intensification with dolutegravir (DTG) + MVC, DTG + Placebo, or Dual - Placebo in PWH with plasma HIV RNA <50 copies/mL on ART and NCI. The primary outcome was the change on the normalized total z score (ie, the mean of individual NC test z scores) at week 48.RESULTS:
Of 357 screened, 191 enrolled 71% male, 51% Black race, 22% Hispanic ethnicity; mean age 52 years; mean CD4+ T-cells 681 cells/µL. Most (65%) had symptomatic HIV-associated NC disorder. Study drug was discontinued due to an adverse event in 15 (8%) and did not differ between arms (P = .17). Total z score, depressive symptoms, and daily functioning improved over time in all arms with no significant differences between them at week 48 or later. Adjusting for age, sex, race, study site, efavirenz use, or baseline z score did not alter the results. Body mass index modestly increased over 96 weeks (mean increase 0.32 kg/m2, P = .006) and did not differ between arms (P > .10).CONCLUSIONS:
This is the largest, randomized, placebo-controlled trial of ART intensification for NCI in PWH. The findings do not support empiric ART intensification as a treatment for NCI in PWH on suppressive ART. They also do not support that DTG adversely affects cognition, mood, or weight.Palabras clave
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Infecciones por VIH
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VIH-1
/
Fármacos Anti-VIH
Tipo de estudio:
Clinical_trials
Límite:
Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Clin Infect Dis
Asunto de la revista:
DOENCAS TRANSMISSIVEIS
Año:
2023
Tipo del documento:
Article
País de afiliación:
Estados Unidos