ReclutandoNCT07650916Registro de ClinicalTrials.gov

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

HIV

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LO ESENCIAL

De qué trata este estudio

El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.

Tipo de estudio: De intervención
Fase: Fase 3
Rango de edad: 12 años - No especificado
Sexo admitido: Todos los sexos
Voluntarios sanos: No aceptados
Participantes: 564 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

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).

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Inclusion criteria:

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).

Exclusion criteria:

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 treatment or prevention of HIV
Previous exposure to injectable CAB and/or injectable 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.

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación: Asignación al azar
Enmascaramiento: Sin enmascaramiento

CAB ULA+ RPV ULA

Participants will receive CAB ULA+RPV ULA.

Drug: CAB ULA · Drug: RPV ULA

CAB LA+ RPV LA

Participants will receive CAB LA+RPV LA.

Drug: CAB LA · Drug: RPV LA

CAB ULA DRUG

CAB ULA will be administered.

RPV ULA DRUG

RPV ULA will be administered.

CAB LA DRUG

CAB LA will be administered.

RPV LA DRUG

RPV LA will be administered.

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

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

Plazo: At Month 11

No informado en este registro.

Medidas secundarias

Percentage of participants with plasma HIV-RNA >= 50 c/mL as per FDA Snapshot algorithm

Plazo: At Month 23

No informado en este registro.

Percentage of participants with plasma HIV-RNA less than (<) 50 c/mL as per FDA Snapshot algorithm

Plazo: At Month 11 and Month 23

No informado en este registro.

Percentage of participants with confirmed virologic failure (CVF)

Plazo: Up to Month 11 and Month 23

CVF is defined as 2 consecutive HIV-1 RNA levels \>=200 c/mL.

Number of participants with drug-related adverse events (AEs) as per severity of Grade 2-5

Plazo: Up to Month 11 and Month 23

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.

Severity is graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading criteria, where Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death.

Number of participants with drug-related serious adverse events (SAEs)

Plazo: Up to Month 11 and Month 23

An SAE is defined as any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongs existing hospitalization, results in disability/incapacity or other medically significant events.

Number of participants who discontinue treatment due to AEs or injection intolerability

Plazo: Up to Month 11 and Month 23

No informado en este registro.

Number of participants with treatment emergent genotypic or phenotypic resistance to CAB and RPV

Plazo: Up to Month 23

No informado en este registro.

Plasma concentrations of CAB and RPV

Plazo: Up to Month 23

No informado en este registro.

Percentage of adolescent participants with plasma HIV-RNA >= 50 c/mL as per FDA Snapshot algorithm

Plazo: At Month 11 and Month 23

No informado en este registro.

Percentage of adolescent participants with plasma HIV-RNA < 50 c/mL as per FDA Snapshot algorithm

Plazo: At Month 11 and Month 23

No informado en este registro.

Percentage of adolescent participants with confirmed virologic failure (CVF)

Plazo: Up to Month 11 and Month 23

CVF is defined as 2 consecutive HIV-1 RNA levels \>=200 c/mL.

Absolute value of Cluster of Differentiation 4 (CD4+) cell counts in adolescent participants

Plazo: Up to Month 11 and Month 23

No informado en este registro.

Change from Baseline in CD4+ cell counts in adolescent participants

Plazo: At Month 11 and Month 23 compared to baseline (Day 1)

No informado en este registro.

Number of adolescent participants with drug-related AEs as per severity of Grade 2-5

Plazo: Up to Month 11 and Month 23

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.

Number of adolescent participants with drug-related SAEs

Plazo: Up to Month 11 and Month 23

Number of adolescent participants who discontinue treatment due to AEs or injection intolerability

Plazo: Up to Month 11 and Month 23

No informado en este registro.

El registro no indica resultados publicados.

Revisa las tablas completas y sus limitaciones en el registro oficial.

Abrir resultados oficiales ↗

Centros de investigación (111)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

Buscar un centro en este estudio

111 centros

GSK Investigational SitePhoenix, Arizona, United StatesReclutando

US GSK Clinical Trials Call CenterCONTACTGSKClinicalSupportHD@gsk.com 877-379-3718

EU GSK Clinical Trials Call CentreCONTACTGSKClinicalSupportHD@gsk.com +44 (0) 20 8990 4466

Douglas CunninghamPRINCIPAL_INVESTIGATOR

De qué trata este estudio

Acerca de la investigación

¿Quién podría participar?

Tratamiento, grupos y participación

Qué evalúan los investigadores

Medidas principales

Medidas secundarias

Centros de investigación (111)

Equipo y fechas

Contactos oficiales del estudio

Consulta a Wellness Clinical Research