Actively Recruiting
Study of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1
Led by Gilead Sciences · Updated on 2026-01-12
75
Participants Needed
21
Research Sites
192 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children and adolescents aged 2 to less than 18 years, with specific weight ranges for each age cohort
- On a complex antiretroviral regimen (more than one tablet or multiple daily doses)
- Documented plasma HIV-1 RNA levels less than 50 copies/mL within the last 6 months prior to screening
- Plasma HIV-1 RNA less than 50 copies/mL at screening
- No documented or suspected resistance to integrase strand transfer inhibitors
- Laboratory parameters at screening: estimated glomerular filtration rate at least 30 mL/min/1.73 m2, absolute neutrophil count greater than 0.50 cells/L (greater than 500 cells/mm3), hemoglobin at least 85 g/L (8.5 g/dL), platelets at least 50 cells/L (50,000 cells/mm3), hepatic transaminases at or below 5 times the upper limit of normal, total bilirubin at or below 23 bcmol/L (1.5 mg/dL), and direct bilirubin at or below 7 bcmol/L (0.4 mg/dL)
You will not qualify if you...
- CD4 cell count less than 200 cells/mm3
- CD4 percentage less than 20%
- Life expectancy of 1 year or less
- Opportunistic illness indicative of Stage 3 HIV diagnosed within 30 days prior to screening
- Active pulmonary or extrapulmonary tuberculosis within 3 months prior to screening
- Acute hepatitis within 30 days prior to screening
- Positive hepatitis C virus antibody with detectable HCV RNA
- Positive hepatitis B surface antigen or positive hepatitis B core antibody at screening, unless HBV DNA is undetectable
- History of or current decompensated liver cirrhosis
- Current alcohol or substance use judged to interfere with study compliance
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 21 locations
1
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
2
University of South Florida
Tampa, Florida, United States, 33612
Actively Recruiting
3
Grady Ponce de Leon Center
Atlanta, Georgia, United States, 30308
Actively Recruiting
4
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60614
Actively Recruiting
5
Helios Salud S.A
Buenos Aires, Argentina, C1141ACG,
Actively Recruiting
6
ASST FBF Sacco Ospedale Sacco
Milan, Italy, 20157
Actively Recruiting
7
IRCCS Ospedale Pediatrico Bambino Gesu, UOS Infezioni Complesse e Perinatali
Roma, Italy, 00165
Actively Recruiting
8
FAMCRU Ukwanda School for Rural Health
Cape Town, South Africa, 7505
Active, Not Recruiting
9
Be Part Yoluntu
Cape Town, South Africa, 7646
Actively Recruiting
10
Durban International Clinical Research Site, Enhancing Care Foundation
Durban, South Africa, 3629
Actively Recruiting
11
Monti Clinical Research Centre
East London, South Africa, 5219
Actively Recruiting
12
Perinatal HIV Research Unit
Johannesburg, South Africa, 1862
Actively Recruiting
13
Wits RHI Shandukani Research Centre CRS
Johannesburg, South Africa, 2038
Actively Recruiting
14
Nkanyezi VIDA Research Unit
Johannesburg, South Africa, 2112
Actively Recruiting
15
Khomanani Health Research and Wellness Centre
Ka-Majosi, South Africa, 944
Actively Recruiting
16
Clinical Research Institute of South Africa (CRISA)
KwaDukuza, South Africa, 4449
Actively Recruiting
17
The Aurum Institute: Pretoria Clinical Research Centre
Pretoria, South Africa, 0087
Actively Recruiting
18
Setshaba Research Centre
Soshanguve, South Africa, 0152
Active, Not Recruiting
19
Hospital General Universitario Gregorio Marano
Madrid, Spain, 28007
Actively Recruiting
20
Hospital Universitario 12 De Octubre
Madrid, Spain, 28041
Actively Recruiting
21
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
Research Team
G
Gilead Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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