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Clinical Trials in Italy / NCT06532656
Active, not recruiting Phase 2/3

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

NCT06532656 · tracked via the Priya Life Science Italy tracker
Phase
Phase 2/3
Started
2024-11-20
Last updated
2026-09-28

Condition(s) studied

HIV-1-infection

Investigational drug(s) / intervention(s)

Lenacapavir →Bictegravir/Lenacapavir (BIC/LEN) FDCBictegravir/Lenacapavir

Lenacapavir: Tablets administered orally without regard to food

Bictegravir/Lenacapavir (BIC/LEN) FDC: Tablets administered orally without regard to food

Bictegravir/Lenacapavir: Tablets administered orally without regard to food

Study summary

The goal of this clinical study is to learn about the safety and tolerability of bictegravir (BIC)/lenacapavir (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.

Eligibility

Sex
ALL
Min age
2 Years
Max age
17 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (21)

FacilityCityRegionStatus
Children's National Hospital Washington D.C. District of Columbia
University of South Florida Tampa Florida
Grady Ponce de Leon Center Atlanta Georgia
Ann and Robert H. Lurie Children's Hospital of Chicago Chicago Illinois
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
Monti Clinical Research Centre East London South Africa
Perinatal HIV Research Unit Johannesburg South Africa
Wits RHI Shandukani Research Centre CRS Johannesburg South Africa
Nkanyezi VIDA Research Unit Johannesburg South Africa
Khomanani Health Research and Wellness Centre Ka-Majosi South Africa
Clinical Research Institute of South Africa (CRISA) KwaDukuza South Africa
The Aurum Institute: Pretoria Clinical Research Centre Pretoria South Africa
Setshaba Research Centre Soshanguve South Africa
Hospital General Universitario Gregorio Marano Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Universitario La Paz Madrid Spain

More Gilead Sciences trials in Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06532656 on ClinicalTrials.gov ↗ ← All trials in Italy