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)
PK Parameter: Cmax of BIC and LEN at Steady State — Day 1 up to Week 24, as appropriate Cmax is defined as the maximum observed concentration of drug at steady state.
PK Parameter: AUCtau of BIC and LEN at Steady State — Day 1 up to Week 24, as appropriate AUCtau is defined as the area under the concentration versus time curve over the dosing interval at steady state.
PK Parameter: Ctrough of BIC and LEN at Steady State — Day 1 up to Week 24, as appropriate Ctrough is defined as the observed drug concentration at the end of the dosing interval at steady state.
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) Through Week 24 — First dose date up to Week 24
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Through Week 24 — First dose date up to Week 24
Trial sites (21)
Facility
City
Region
Status
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
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.
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