A Phase 3, Randomized, Double-blind, Active-controlled Study to Evaluate a Switch to an Oral Weekly Islatravir/Lenacapavir Regimen in People With HIV-1 Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF)

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT06630286Tipo: INTERVENTIONALInicio: 9 de oct de 2024Fin estimado: 1 de ago de 2030

Traducción no disponible, mostrando original

Resumen

The goal of this clinical study is to learn about the safety and efficacy of switching to once weekly tablet of islatravir/lenacapavir (ISL/LEN) regimen versus continuing standard treatment of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in people with human immunodeficiency virus (PWH) who are virologically suppressed (HIV-1 RNA levels \< 50 copies/mL) on B/F/TAF for ≥ 6 months prior to screening. The primary objective is to evaluate the efficacy of switching to oral weekly ISL/LEN tablet regimen versus continuing B/F/TAF in virologically suppressed PWH at Week 48.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

HIV-1 RNA \< 50 copies/mL for ≥ 6 months before screening, as documented by:
One HIV-1 RNA \< 50 copies/mL immediately preceding the 24 week period prior to screening.
Within 24 weeks prior to screening, if HIV-1 RNA results are available, all levels must be \< 50 copies/mL.
During the 6 to 12 months period prior to screening, transient detectable viremia ≥ 50 copies/mL is acceptable ("blip"), as long as it is not confirmed on 2 consecutive visits.
Plasma HIV-1 RNA levels \< 50 copies/mL at screening.
Individuals are receiving B/F/TAF for ≥ 6 months prior to screening and willing to continue until Day 1.
Individuals assigned female at birth and of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified methods of contraception.

Criterios de exclusión

Prior virologic failure.
Prior use of, or exposure to ISL or LEN.
Active, serious infections requiring parenteral therapy within 30 days before randomization.
Active tuberculosis infection.
Acute hepatitis within 30 days before randomization.
Hepatitis B virus (HBV) infection as determined below at the screening visit:
Positive HBV surface antigen OR
Positive HBV core antibody and negative HBV surface antibody. Note: individuals found to be susceptible to HBV infection (eg negative hepatitis B surface antibody at the screening visit, regardless of prior HBV vaccination history) should be recommended to receive HBV vaccination.
Active hepatitis C virus (HCV) coinfection, defined as detectable HCV RNA. Note: individuals with prior/inactive HCV infection (defined as undetectable HCV RNA) may be enrolled.
Any of the following laboratory values at screening:
Creatinine clearance (CLcr) ≤ 30 mL/min according to the Cockcroft-Gault formula
Alanine aminotransferase \> 5 x upper limit of normal (ULN)
Direct bilirubin \> 1.5 x ULN
Platelets \< 50,000/μL
Hemoglobin \< 8.0 g/dL

Intervenciones

drug

ISL/LEN

Tablet administered orally

drug

B/F/TAF

Tablet administered orally

drug

PTM B/F/TAF

Tablet administered orally

drug

PTM ISL/LEN

Tablet administered orally

Ubicaciones

Fundacion Huesped

Buenos Aires, Argentina

Helios Salud S.A.

Buenos Aires, Argentina

Patrocinadores

PrincipalGilead Sciences

ColaboradorMerck Sharp & Dohme LLC

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