OVERVIEW
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
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.
View moreParticipation requirements
Age
2 years - 17 years
Sex
All
Healthy Volunteers
No
Age
2 years - 17 years
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
HIV-1-infection
Gender
N/A
Date
November 2024 - July 2030
Study Type
Interventional
Study Phase
Phase 2, Phase 3
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 (21)
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60614
IRCCS Ospedale Pediatrico Bambino Gesu, UOS Infezioni Complesse e Perinatali
Roma, Italy, 00165
Durban International Clinical Research Site, Enhancing Care Foundation
Durban, South Africa, 3629
Wits RHI Shandukani Research Centre CRS
Johannesburg, South Africa, 2038
Khomanani Health Research and Wellness Centre
Ka-Majosi, South Africa, 944
Clinical Research Institute of South Africa (CRISA)
KwaDukuza, South Africa, 4449
The Aurum Institute: Pretoria Clinical Research Centre
Pretoria, South Africa, 0087
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