A Study to Investigate Cabotegravir Ultra Long-Acting (CAB ULA) Plus Rilpivirine Ultra Long-Acting (RPV ULA) in Adults and Adolescents With HIV Who Are Virologically Suppressed

Официальное название

A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Cabotegravir Ultra Long-acting Plus Rilpivirine Ultra Long-acting or Cabotegravir Long-acting Plus Rilpivirine Long-acting in Adults and Adolescents With HIV Who Are Virologically Suppressed on ART

Обзор

This study compares the efficacy, safety and tolerability of CAB ULA and RPV ULA administered with CAB long acting (LA) and RPV LA administered in adults and adolescents with HIV who are virologically suppressed on anti-retroviral therapy (ART).

Вмешательства

• Препарат CAB ULA
  CAB ULA will be administered.
• Препарат RPV ULA
  RPV ULA will be administered.
• Препарат CAB LA
  CAB LA will be administered.
• Препарат RPV LA
  RPV LA will be administered.

Первичные конечные точки

• Percentage of participants with plasma HIV-RNA greater than or equal to (>=) 50 copies (c)/mL as per Food and Drug Administration (FDA) Snapshot algorithm [Срок оценки: At Month 11]

Вторичные конечные точки (12)

• Percentage of participants with plasma HIV-RNA >= 50 c/mL as per FDA Snapshot algorithm [Срок оценки: At Month 23]
• Percentage of participants with plasma HIV-RNA less than (<) 50 c/mL as per FDA Snapshot algorithm [Срок оценки: At Month 11 and Month 23]
• Percentage of participants with confirmed virologic failure (CVF) [Срок оценки: Up to Month 23]
• Number of participants with drug-related adverse events (AEs) as per severity of Grade 2-5 [Срок оценки: Up to Month 23]
• Number of participants with drug-related serious adverse events (SAEs) [Срок оценки: Up to Month 23]
• Number of participants who discontinue treatment due to AEs or injection intolerability [Срок оценки: Up to Month 23]
• Number of participants with treatment emergent genotypic or phenotypic resistance to CAB and RPV [Срок оценки: Up to Month 23]
• Ctrough of CAB and RPV [Срок оценки: Up to Month 23]
• Maximum concentrations post dose (Cmax) of CAB and RPV [Срок оценки: Up to Month 23]
• Area under the curve (AUC) of CAB and RPV [Срок оценки: Up to Month 23]
• Absolute value of CD4+ cell counts in participants [Срок оценки: Up to Month 23]
• Change from Baseline in CD4+ cell counts in participants [Срок оценки: At Month 23 compared to baseline (Day 1)]

Критерии участия

Критерии включения

Patient Study Participant (PSP) Inclusion criteria:

• Adults and adolescents with HIV-1 infection aged 12 years or older with a weight >35 kg.
• Documented HIV-1 RNA measurements <50 copies/mL in the 12 months prior to Screening.
• HIV-1 RNA <50 copies/mL at screening assessment.
• Must be on current daily oral antiretroviral regimen for at least 6 months uninterrupted prior to Screening.
• Any prior switch in therapy must have occurred due to tolerability/safety, access to medications, or convenience/simplification, and must NOT have been done for virologic treatment failure (HIV-1 RNA ≥200 copies/mL).

Критерии исключения

Patient Study Participant (PSP) Exclusion criteria:

• Any evidence of primary resistance based on the presence of any major known INSTI (including CAB) or NNRTI (including RPV) resistance-associated mutation.
• Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of screening.
• Any history of receiving long-acting therapy for HIV.
• Previous exposure to CAB and/or RPV for treatment or prevention of HIV-1 infection.
• Significant uncontrolled or clinically relevant comorbidities (e.g., cardiovascular, hepatic, renal, neurological, psychiatric) that may impact safety or study participation.

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

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 35 центров

• GSK Investigational Site — Phoenix
• GSK Investigational Site — Bakersfield
• GSK Investigational Site — Los Angeles
• GSK Investigational Site — Los Angeles
• GSK Investigational Site — San Diego
• GSK Investigational Site — New Haven
• GSK Investigational Site — Washington D.C.
• GSK Investigational Site — DeLand
• … и ещё 27 центров

Аргентина · 7 центров

• GSK Investigational Site — Buenos Aires
• GSK Investigational Site — Buenos Aires
• GSK Investigational Site — Buenos Aires
• GSK Investigational Site — Ciudad Autonoma Buenos Aires
• GSK Investigational Site — Ciudad Autonoma Buenos Aires
• GSK Investigational Site — Córdoba
• GSK Investigational Site — San Miguel de Tucumán

Канада · 4 центра

• GSK Investigational Site — Vancouver
• GSK Investigational Site — Toronto
• GSK Investigational Site — Montreal
• GSK Investigational Site — Montreal

Япония · 4 центра

• GSK Investigational Site — Aichi
• GSK Investigational Site — Kanagawa
• GSK Investigational Site — Osaka
• GSK Investigational Site — Tokyo

Австралия · 3 центра

• GSK Investigational Site — Darlinghurst
• GSK Investigational Site — Sydney
• GSK Investigational Site — Taringa

Пуэрто-Рико · 1 центр

• GSK Investigational Site — San Juan

Идентификаторы

NCT: NCT07650916 · 222794 · 2024-518511-19-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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