A Continued Access Study for Participants Transitioning From ViiV Healthcare-sponsored or ViiV Healthcare-collaborative Parent Studies for HIV Treatment

Официальное название

A Phase 3b, Open-label, Multicenter, Continued Access Study for Participants Transitioning From ViiV Healthcare Sponsored or ViiV Healthcare Collaborative Parent Studies for HIV Treatment

Обзор

The purpose of this study is to provide continued access to the study treatment for participants from previous ViiV Healthcare studies who are still benefiting from it and do not have local access after completing the parent study. This continued access will also allow further collection of safety data. Eligible participants are those who completed a ViiV Healthcare-sponsored or collaborative parent study and are currently experiencing clinical benefit. The Sponsor will periodically review the study to consider other treatment access options.

Вмешательства

• Препарат Fostemsavir
  Participants receive oral tablets with the dosages depending on the weight of the participants.
• Препарат Dolutegravir (DTG)/ Lamivudine (3TC)
  Participants receive oral tablets with the dosages depending on the weight of the participants.

Первичные конечные точки

• Number of participants who discontinue the study intervention and the reason for discontinuation [Срок оценки: Throughout the study period (from rollover visit at Day 1 until the end of study/withdrawal visit)]
• Number of participants with serious adverse events (SAE) [Срок оценки: Throughout the study period (from rollover visit at Day 1 until the end of study /withdrawal visit)]
• Number of participants with adverse events of special interest (AESI) [Срок оценки: Throughout the study period (from rollover visit at Day 1 until the end of study /withdrawal visit)]

Критерии участия

Критерии включения

Participants are eligible to be included in this study only if all the following criteria apply:

• Investigator confirmation of the participant's continued clinical benefit from the parent study intervention and the participant's completion of the protocol-defined treatment period in the parent study. The Investigator should ensure that the participant is still eligible for the parent study (i.e., have not met parent study discontinuation/ withdrawal criteria).
• Participants or legally authorized representative (LAR) who are willing and able to comply with all scheduled visits, treatment plan, and other study procedures as outlined in the applicable appendix and determined by the Investigator.
• Participant or LAR is able and willing to provide signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and this protocol. Where applicable, participants must provide written assent.

Критерии исключения

Participants are excluded from participating in this study if the following criterion applies:

• Any reason that, in the opinion of the Investigator or Sponsor, precludes the participant's inclusion in the study.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07393659 · 300269

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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