A Phase 2/3, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1

ReclutandoFase 3ClinicalTrials.gov

ID: NCT06532656Tipo: INTERVENTIONALInicio: 20 de nov de 2024Fin estimado: 1 de ago de 2028

Traducción no disponible, mostrando original

Resumen

The goal of this clinical study is to learn about the safety and tolerability of bictegravir/lenacapavir (BIC/LEN) and to learn how the study drug interacts with the body in virologically suppressed (VS) children and adolescents with human immunodeficiency virus type 1 (HIV-1) on a stable and complex antiretroviral (ARV) regimen. The study will also assess the safe loading dose of LEN and pharmacokinetics (PK) of BIC/LEN. The primary objectives of this study are: * To evaluate the steady-state PK of BIC and LEN and confirm the dose of the LEN loading dose and BIC/LEN FDC in VS children and adolescents with HIV-1. * To evaluate the safety and tolerability of BIC/LEN through Week 24 in VS children and adolescents with HIV-1.

Elegibilidad

Edad mínima: 2 YearsEdad máxima: 17 YearsSexo: ALL

Criterios de inclusión

Age and body weight at screening:
Cohort 1: ≥ 12 years to \< 18 years weighing ≥ 35 kg.
Cohort 2: ≥ 6 years to \< 12 years weighing ≥ 25 kg to \< 35 kg.
Cohort 3: ≥ 2 years to \< 6 years weighing ≥ 10 kg to \< 25 kg.
On a complex ARV regimen. Complex regimens are any ARV therapy that is not a single-tablet regimen taken once daily (eg, \> 1 tablet or any other formulation a day).
Documented plasma HIV-1 ribonucleic acid (RNA) levels must be \< 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is \< 50 copies/mL) in the last 6 months prior to screening (at least 1 measure prior to screening).
Plasma HIV-1 RNA levels \< 50 copies/mL at screening.
No documented or suspected resistance to integrase strand transfer inhibitors (mutations T66A/I/K, E92G/Q/V, G118R, F121C/Y, G140R, Y143C/H/R, S147G, Q148H/K/R, N155H/S, or R263K in the integrase gene).
The following laboratory parameters at screening:
Estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2 using the Bedside Schwartz formula.
Absolute neutrophil count \> 0.50 cells/L (\> 500 cells/mm3).
Hemoglobin ≥ 85 g/L (\> 8.5 g/dL).
Platelets ≥ 50 cells/L (≥ 50,000 cells/mm3).
Hepatic transaminases (aspartate aminotransferase and alanine aminotransferase)
≤ 5 x upper limit of normal.
Total bilirubin ≤ 23 μmol/L (≤ 1.5 mg/dL) and direct bilirubin ≤ 7 μmol/L (≤ 0.4 mg/dL).

Criterios de exclusión

CD4 cell count \< 200 cells/mm\^3.
CD4 percentage \< 20%.
Life expectancy ≤ 1 year.
An opportunistic illness indicative of Stage 3 HIV diagnosed within the 30 days prior to screening.
Evidence of active pulmonary or extrapulmonary tuberculosis within 3 months prior to screening.
Acute hepatitis within 30 days prior to screening.
Positive hepatitis C virus (HCV) antibody with detectable HCV RNA (participants positive for HCV antibody will have an HCV RNA test performed).
Positive hepatitis B surface antigen (HBsAg) or positive hepatitis B virus (HBV) core antibody (antibody against hepatitis B core antigen \[anti-HBc\]) at screening. If a participant is negative for HBsAg and positive for anti-HBc but HBV DNA is undetectable, the participant may be enrolled.
A history of or current decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding).Current alcohol or substance use judged by the investigator to potentially interfere with the participant's study compliance.

Intervenciones

drug

Lenacapavir

Tablets administered orally without regard to food

drug

BIC/LEN FDC

Tablets administered orally without regard to food

Ubicaciones

Helios Salud S.A

Buenos Aires, Argentina

RECRUITING

Patrocinadores

PrincipalGilead Sciences

Contactos

Gilead Clinical Study Information Center

CONTACT

GileadClinicalTrials@gilead.com 1-833-445-3230 (GILEAD-0)

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

A Phase 2/3, Open-Label Study to Evaluate the Pharmacokin... | EligiMed