An Operationally Seamless Phase 2/3 Randomized, Open-label, Multicenter, Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Stable Baseline Regimen in Virologically Suppressed People With HIV-1 on Stable Complex Treatment Regimens

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT05502341Tipo: INTERVENTIONALInicio: 16 de ago de 2022Fin estimado: 1 de jul de 2028

Traducción no disponible, mostrando original

Resumen

The goal of this clinical study is to learn more about the effects of switching to the study drugs, bictegravir (BIC) plus lenacapavir (LEN), versus current therapy (Phase 2) and BIC/LEN fixed-dose combination (FDC) versus current therapy (Phase 3) in people living with HIV (PWH).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

If plasma HIV-1 RNA measurements in the 6 months prior to screening are available, all levels must be \< 50 copies/mL.
At least one documented plasma HIV-1 RNA level measured between 6 and 12 months (± 2 months) prior to screening. This and any other HIV-1 RNA measurements documented in this period must be \< 50 copies/mL
Plasma HIV-1 RNA levels \< 50 copies/mL at screening.
Currently receiving a complex antiretroviral (ARV) regimen due to previous viral resistance, or intolerance, or contraindication to existing single-tablet regimens (STR), and on this regimen for at least 6 months prior to the screening visit. The criteria to define a complex regimen in this study are as follows:
A regimen containing a boosted protease inhibitor or a nonnucleos(t)ide reverse transcriptase inhibitor (NRTI) plus at least 1 other third agent (ie, an agent from a class other than NRTIs) (eg, bictegravir/emtricitabine/tenofovir alafenamide (coformulated; Biktarvy®)(BVY) + darunavir/cobicistat, BVY + etravirine), or
A regimen of ≥ 2 pills/day, or a regimen requiring dosing more than once daily, or
A regimen containing parenteral agent(s) (excluding a complete long-acting injectable regimen, such as intramuscular cabotegravir plus rilpivirine) as well as oral agents.
No documented or suspected resistance to bictegravir (BIC).
Estimated glomerular filtration rate ≥ 15 mL/min according to the Cockcroft-Gault formula for creatinine clearance (CLcr) who are not on renal replacement therapy.

Criterios de exclusión

Prior use of, or exposure to, lenacapavir (LEN)
Active tuberculosis infection
Chronic hepatitis B virus (HBV) infection

Intervenciones

drug

Bictegravir

Tablets administered orally without regard to food

drug

Lenacapavir

Tablets administered orally without regard to food

drug

BIC/LEN FDC

Tablets administered orally without regard to food

drug

Stable Baseline Regimen

SBR will include a combination of antiretroviral (ARV) regimen. ARV regimen may include the following, except for participants taking a single tablet regimen or taking a complete parenteral regimen (Cabenuva). * Nucleos(t)ide Reverse Transcriptase Inhibitors: * Abacavir * Emtricitabine * Lamivudine * Tenofovir alafenamide * Tenofovir disoproxil fumarate * Zidovudine * Non-Nucleosite Reverse Transcriptase Inhibitors: * Delavirdine * Efavirenz * Nevirapine * Rilpivirine * Doravirine * Integrase Inhibitors: * Bictegravir * Cabotegravir * Dolutegravir * Elvitegravir * Raltegravir * Protease Inhibitors: * Atazanavir * Darunavir * Fosamprenavir * Indinavir * Lopinavir * Nelfinavir * Saquinavir * Tipranavir * Chemokine Co-receptor 5 (CCR5) Antagonist: * Maraviroc * Fusion Inhibitors: * Enfuvirtide * gp120 Attachment Inhibitor: * Fostemsavir * Anti-CD4 Monoclonal Antibodies: * Ibalizumab-uiyk

Ubicaciones

Hospital General de Agudos J.M Ramon Mejia

Buenos Aires, Argentina

Fundación Huésped

Buenos Aires, Argentina

Helios Salud

Buenos Aires, Argentina

Patrocinadores

PrincipalGilead Sciences

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