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Идёт набор NCT00796263

Antiretroviral Therapy for Acute and Chronic HIV Infection

Фаза III С лечением Acute HIV Infection Chronic HIV Infection

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: HAART.
Кому может быть актуально
Состояния в реестре: Acute HIV Infection, Chronic HIV Infection. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Таиланд
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The purpose for this protocol is to provide safe and effective standard ART to SEARCH 010 and SEARCH 013 participants. Participants are enrolled in an acute HIV infection study (SEARCH 010 protocol: 'Establish and characterize an acute HIV infection cohort in a Thai high-risk population') or in a study of chronic HIV infection (SEARCH 013 protocol 'Characteristics of immunity in gut mucosa, spinal fluid, lymph node and blood of HIV negative and HIV positive Thais').

Подробное описание

To compare systemic and tissue compartments (genital secretion, CNS, gut and lymph node) outcomes among individuals who initiate HIV treatment during acute vs. chronic HIV infection. The outcomes will be compared by stages of infection and antiretroviral regimens. Participants are enrolled in an acute HIV infection study (SEARCH 010 protocol: 'Establish and characterize an acute HIV infection cohort in a Thai high-risk population') or in a study of chronic HIV infection (SEARCH 013 protocol 'Characteristics of immunity in gut mucosa, spinal fluid, lymph node and blood of HIV negative and HIV positive Thais') with the latter serving as controls for the acutely infected individuals.

Вмешательства

  • Препарат HAART
    1 (lamivudine) or 2 (lamivudine + abacavir) nuceloside/nucleotide analog reverse-transcriptase inhibitor (NRTI) class medications once daily plus dolutegravir(DTG) 50 mg orally once daily

Первичные конечные точки

  • HIV-related clinical events [Срок оценки: 10 years]
  • Immunologic parameters including CD4 count and CD4/CD8 ratio [Срок оценки: 10 years]
  • Virologic parameters including HIV RNA and HIV reservoir markers [Срок оценки: 10 years]
Вторичные конечные точки (9)
  • Adverse events related to HAART initiated during acute HIV infection as assessed by DAIDS grading table version 2.1 [Срок оценки: 10 years]
  • Adherence to ART [Срок оценки: 10 years]
  • Frequency and functional status of HIV-specific CD8+ T cells in blood and tissue compartments (genital secretion, CSF, gut and lymph node) [Срок оценки: 10 years]
  • Expression of non-specific activation markers on CD8+ T cells in blood and tissue compartments (genital secretion, CSF, gut and lymph node) [Срок оценки: 10 years]
  • HIV drug resistance by genotyping at study baseline and in case of virological failure after viral suppression. [Срок оценки: 10 years]
  • Assessment of immune activation markers by multiplex technology in blood plasma, CSF and colon and lymph node cell suspension [Срок оценки: 10 years]
  • Determination of Z-score of 4 neuropsychological tests of motor and processing speed, the so-called NPZ4 score. [Срок оценки: 10 years]
  • Assessment of functional brain magnetic resonance imaging and magnetic resonance spectroscopy [Срок оценки: 10 years]
  • Assessment of impact of co-morbid infections on CD4 count, CD4/CD8 ratio and HIV VL [Срок оценки: 10 years]

Критерии участия

Критерии включения

  • Age ≥ 18 years old
  • Enrolled in the SEARCH 010 or 013 protocols with documentation of acute or chronic protocol defined HIV-1 infection and chooses to initiate or continue ART
  • Understand the study and sign informed consent form. Persons who cannot read will have the consent form read and explained to them by a member of the study staff and they can give informed consent by using their thumb print
  • Availability for follow-up for the planned study duration

Критерии исключения

1\. Persons who have a history of a medical or psychiatric disorder by investigator's interview and physical examination according to standard practices, that in the judgment of the investigator(s), would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Таиланд · 1 центр
  • Institute of HIV Research and Innovation — Bangkok

Публикации

  • Ananworanich J, Eller LA, Pinyakorn S, Kroon E, Sriplenchan S, Fletcher JL, Suttichom D, Bryant C, Trichavaroj R, Dawson P, Michael N, Phanuphak N, Robb ML. Viral kinetics in untreated versus treated acute HIV infection in prospective cohort studies in Thailand. J Int AIDS Soc. 2017 Jun 26;20(1):21652. doi: 10.7448/IAS.20.1.21652. PMID 28691436
  • de Souza MS, Pinyakorn S, Akapirat S, Pattanachaiwit S, Fletcher JL, Chomchey N, Kroon ED, Ubolyam S, Michael NL, Robb ML, Phanuphak P, Kim JH, Phanuphak N, Ananworanich J; RV254/SEARCH010 Study Group. Initiation of Antiretroviral Therapy During Acute HIV-1 Infection Leads to a High Rate of Nonreactive HIV Serology. Clin Infect Dis. 2016 Aug 15;63(4):555-61. doi: 10.1093/cid/ciw365. Epub 2016 Jun PMID 27317797

Идентификаторы

NCT: NCT00796263 · HAART for Acute HIV infection

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗