A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments

Официальное название

An Open-label, Single-arm Study to Provide Continued Access to Study Drug to Participants Who Have Completed Pediatric Clinical Studies Involving Gilead HIV Treatments

Обзор

The goal of this clinical study is to provide continued access to the study drug(s) to children and adolescents with human immunodeficiency virus type 1 (HIV-1) who completed their participation in an applicable parent study and to monitor for adverse events. The primary objectives of this study are as follows: * To provide continued access to the study drug received in the parent protocol or switch to bictegravir/emtricitabine/tenofovir (B/F/TAF) for participants who completed a Gilead parent study evaluating drugs for HIV treatment. * To evaluate the safety of the study drug(s) in participants with HIV-1.

Вмешательства

• Препарат F/TAF (High Dose Tablet)
  200/25 mg fixed-dose combination (FDC) tablet administered orally
• Препарат F/TAF (Low Dose Tablet)
  200/10 mg FDC tablet administered orally
• Препарат F/TAF (Lowest Dose Tablet)
  120/15 mg FDC tablet administered orally
• Препарат F/TAF (High Dose TOS)
  60/7.5 mg tablet for oral suspension (TOS) administered orally
• Препарат F/TAF (Low Dose TOS)
  30/3.75 mg TOS administered orally
• Препарат F/TAF (Lowest Dose TOS)
  15/1.88 mg TOS administered orally
• Препарат E/C/F/TAF
  150/150/200/10 mg tablet administered orally
• Препарат E/C/F/TAF (Low Dose)
  90/90/120/6 mg tablet administered orally
• Препарат Cobicistat (High Dose)
  150 mg tablet administered orally
• Препарат Cobicistat (Low Dose)
  90 mg tablet administered orally

Первичные конечные точки

• Number of Eligible Participants Who Have Received Access to the Study Drug(s) in the Study [Срок оценки: Up to 9.5 Years]

Вторичные конечные точки (1)

• Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) [Срок оценки: Up to 9.5 Years]

Критерии участия

Критерии включения

• Completed an applicable parent study: GS-US-292-0106, GS-US-380-1474, GS-US-311-1269, or GS-US-216-0128, and gave consent to study participation.

Критерии исключения

• Individuals planning to switch to B/F/TAF on Day 1 with plasma HIV RNA ≥ 50 copies/mL during the last parent study visit prior to screening/Day 1 visit.

• Note: individuals planning to switch after Day 1 must not have plasma HIV RNA ≥ 50 copies/mL (or detectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL).
• Individuals planning to switch to B/F/TAF with any ongoing Grade 3 or 4 drug-related AE or clinically relevant Grade 3 or 4 drug-related laboratory abnormality (confirmed on repeat) related to any component of B/F/TAF prior to treatment switch.
• For those on B/F/TAF or planning to switch to B/F/TAF: previous treatment discontinuation of any component of B/F/TAF due to toxicity or intolerance.
• For those planning to switch to B/F/TAF: known hypersensitivity to any component of the study drug, its metabolites, or formulation excipients.
• Ongoing treatment with or prior use of any prohibited medications.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

ЮАР · 7 центров

• University of Stellenbosch — Cape Town
• Enhancing Care Foundation — Durban
• WITS RHI Research Centre — Johannesburg
• Rahima Moosa Mother and Child Hospital — Johannesburg
• Be Part Yoluntu Centre — Paarl
• The Aurun Institute — Pretoria
• Perinatal HIV Research Unit — Soweto

Uganda · 3 центра

• Joint Clinical Research Centre — Kampala
• MU-JHU Research Collaboration/MU-JHU Care Ltd — Kampala
• Baylor College of Medicine — Kampala

Таиланд · 2 центра

• Faculty of Medicine - Mahidol University — Bangkok Noi
• Khon Kaen University — Khon Kaen

Аргентина · 1 центр

• Helios Salud — Buenos Aires

Panama · 1 центр

• Hospital del Niño — Panama City

Zimbabwe · 1 центр

• University of Zimbabwe Clinical Research Centre — Harare

Идентификаторы

NCT: NCT06337032 · GS-US-380-6684 · 2024-000521-40

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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