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Идёт набор NCT06507059

Outcomes of the PLHIV With Suboptimal Viral Suppression to Injectable Long-acting Antiretrovirals

Фаза III С лечением HIV-1-infection Non-Adherence, Medication

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: cabotegravir/rilpivirine (600mg/ 900mg), Antiretroviral Combinations.
Кому может быть актуально
Состояния в реестре: HIV-1-infection, Non-Adherence, Medication. 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
Тайвань
Следующий шаг
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Официальное название

A Phase 3 Study Comparing Clinical Outcomes in People Living With HIV (PLHIV) With Suboptimal Adherence Treated With Injectable Long-acting Antiretrovirals Versus Oral Antiretrovirals

Обзор

This study aims to determine whether people living with HIV (PLHIV) with suboptimal medical adherence can achieve better viral suppression with long-acting antiretrovirals (LA) compared to all-oral antiretrovirals.

Подробное описание

This is an open-label, multi-center, randomized, active-controlled, superiority trial on 40 adult subjects who had been diagnosed to have HIV infection for at least 12 months before enrollment but with suboptimal viral suppression despite antiretroviral treatment (ART), with the latest HIV-1 viral load ≥ 200 copies/mL. Participants' eligibility will be assessed through a review of their medical records, and individuals with established resistance to cabotegravir or rilpivirine will be excluded. Enrolled participants will then be randomized 1:1 to either "Delayed Switch to LA Treatment Group" or "Immediate LA Treatment Group" on enrollment. The "Delayed Switch to LA Treatment Group" will also switch to LA on week 24. The proportion of participants with HIV-1 RNA \<200 copies/mL at week 24 in the two study groups will be compared. Psychologic assessments including self-stigma and depression assessment will also be performed on day1, at week 24 and week 52.

Вмешательства

  • Препарат cabotegravir/rilpivirine (600mg/ 900mg)
    Immediate switch from oral antiretroviral to long-acting injectables
  • Препарат Antiretroviral Combinations
    Standard all-oral antiretroviral combinations

Первичные конечные точки

  • HIV-1 RNA <200 copies/mL [Срок оценки: Week 24]
Вторичные конечные точки (12)
  • HIV-1 RNA <50 copies/mL [Срок оценки: Week 24, week 52]
  • HIV-1 RNA <200 copies/mL [Срок оценки: Week 52]
  • Change of plasma HIV-1 viral load [Срок оценки: Week 24, week 52]
  • Change of CD4 count [Срок оценки: Week 24, week 52]
  • Occurrence of HIV and non-HIV related conditions [Срок оценки: Week 24, week 52]
  • Lost F/U rate [Срок оценки: up to week 96]
  • Usage of outreach drug delivery service [Срок оценки: up to week 52]
  • Resistant variant emergence [Срок оценки: Week 24, week 52]
  • Adverse events [Срок оценки: Week 24, week 52]
  • Discontinuation due to AEs [Срок оценки: Week 24, week 52]
  • Change of depression score [Срок оценки: Week 24, week 52]
  • Change of self-stigma score [Срок оценки: Week 24, week 52]

Критерии участия

Критерии включения

  • Willing to sign the written informed consent form for male and female participants aged 18 and above.
  • At the time of enrollment, diagnosed with HIV infection for a minimum of 12 months.
  • Under oral antiretroviral treatment (ART), which can be irregular or interrupted, with the most recent viral load ≥ 200 copies/mL.
  • Body weight ≥ 35Kg.
  • Willing to maintain contact with the research team throughout the study (provide accurate and reachable phone numbers, social accounts like Line, or reliable contact information of family or friends).
  • Willing to receive gluteal (buttocks) drug injections.
  • Willing to transition back to oral medication or follow the recommended treatment prescription according to the then-current national treatment guidelines after discontinuation of long-acting injectable drugs.

Критерии исключения

  • For those currently undergoing oral antiretroviral therapy, who have started or restarted oral ART for less than six consecutive months before screening.
  • Previously undergone HIV drug resistance testing and known to have resistance mutations to either cabotegravir or rilpivirine.
  • Unable to commit to maintaining contact with the research team throughout the study.
  • Individuals who cannot receive treatment for hepatitis B during the period of transitioning to long-acting injections, if they are hepatitis B carriers.
  • Individuals with buttock fillers.
  • Women who are planning to become pregnant, pregnant, or currently breastfeeding.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Тайвань · 4 центра
  • Chang Gung Memorial Hospital, Keelung — Keelung
  • Chang Gung Memorial Hospital, Taipei — Taipei
  • Taoyuan General Hospital, Ministry of Health and Welfare — Taoyuan
  • Chang Gung Memorial Hospital, Linkou — Taoyuan

Идентификаторы

NCT: NCT06507059 · 202301496A3 · MOHW113-CDC-C-114-000106

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗