Study of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1

Phase 3Active Not RecruitingNCT06532656

Gilead Sciences75 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV-1-infection

Interventions

Eligibility

Sex: ALLMin age: 2 YearsMax age: 17 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * 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). Key Exclusion Criteria: * 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. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations (21)

Children's National Hospital

Washington D.C., District of Columbia, United States

University of South Florida

Tampa, Florida, United States

Grady Ponce de Leon Center

Atlanta, Georgia, United States

Ann and Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Helios Salud S.A

Buenos Aires, Argentina

ASST FBF Sacco Ospedale Sacco

Milan, Italy

IRCCS Ospedale Pediatrico Bambino Gesu, UOS Infezioni Complesse e Perinatali

Roma, Italy

FAMCRU Ukwanda School for Rural Health

Cape Town, South Africa

Be Part Yoluntu

Cape Town, South Africa

Durban International Clinical Research Site, Enhancing Care Foundation

Durban, South Africa

...and 11 more locations

Outcomes

Primary Outcomes

PK Parameter: Cmax of BIC and LEN at Steady State

Cmax is defined as the maximum observed concentration of drug at steady state.

Time frame: Day 1 up to Week 24, as appropriate

PK Parameter: AUCtau of BIC and LEN at Steady State

AUCtau is defined as the area under the concentration versus time curve over the dosing interval at steady state.

Time frame: Day 1 up to Week 24, as appropriate

PK Parameter: Ctrough of BIC and LEN at Steady State

Ctrough is defined as the observed drug concentration at the end of the dosing interval at steady state.

Time frame: Day 1 up to Week 24, as appropriate

Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) Through Week 24

Time frame: First dose date up to Week 24

Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Through Week 24

Time frame: First dose date up to Week 24

Secondary Outcomes

PK Parameter: AUClast for BIC and LEN at Steady State

AUClast is defined as the area under the concentration versus time curve from time zero to the last quantifiable concentration at steady state.