Study Details

PROTOCOL SUMMARY

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.

Participation Requirements

Age

2 Years - 17 Years

Sex

ALL

Healthy Volunteers

Medical Condition

HIV-1-infection

Gender

N/A

Date

November 2024 - February 2028

Study Type

INTERVENTIONAL

Study Phase

PHASE2, PHASE3

Product

Lenacapavir, BIC/LEN FDC

Eligibility Information

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).

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

Locations (17)

Children's National Hospital

Washington, District of Columbia, United States, 20010

University of South Florida

Tampa, Florida, United States, 33612

Grady Ponce de Leon Center

Atlanta, Georgia, United States, 30308

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

Chicago, Illinois, United States, 60614

Helios Salud S.A

Buenos Aires, Argentina, C1141ACG,

ASST FBF Sacco Ospedale Sacco

Milano, Italy, 20157

IRCCS Ospedale Pediatrico Bambino Gesu, UOS Infezioni Complesse e Perinatali

Roma, Italy, 00165

Be Part Yoluntu

Cape Town, South Africa, 7646

Durban International Clinical Research Site, Enhancing Care Foundation

Durban, South Africa, 3629

Perinatal HIV Research Unit

Johannesburg, South Africa, 1862

Wits RHI Shandukani Research Centre CRS

Johannesburg, South Africa, 2038

The Aurum Institute: Pretoria Clinical Research Centre

Pretoria, South Africa, 0087

Setshaba Research Centre

Soshanguve, South Africa, 0152

FAMCRU Ukwanda School for Rural Health

Worcester, South Africa, 6849

Hospital General Universitario Gregorio Marano

Madrid, Spain, 28007

Hospital Universitario 12 De Octubre

Madrid, Spain, 28041

Hospital Universitario La Paz

Madrid, Spain, 28046

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

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