Estudio multicéntrico, abierto, aleatorizado, controlado ... | EligiMed

Estudio multicéntrico, abierto, aleatorizado, controlado activo, operacionalmente continuo, de fase 2/3, para evaluar la seguridad y eficacia de bictegravir/lenacapavir frente al régimen de base estable en personas con VIH-1 virológicamente suprimidas en regímenes de tratamiento complejos estables

Activo, no reclutaFase 3ClinicalTrials.gov

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

Resumen

El objetivo de este estudio clínico es obtener más información sobre los efectos del cambio a los fármacos del estudio, bictegravir (BIC) más lenacapavir (LEN), frente a la terapia actual (fase 2), y la combinación en dosis fija (CDF) BIC/LEN frente a la terapia actual (fase 3), en personas que viven con VIH (PVV).

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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