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

Status: Recruiting
Location: See all (19) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 17
Healthy Volunteers: f
View:

• 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.

• 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).

Locations
United States
Washington, D.c.
Children's National Hospital
RECRUITING
Washington D.c.
Florida
University of South Florida
RECRUITING
Tampa
Georgia
Grady Ponce de Leon Center
RECRUITING
Atlanta
Illinois
Ann and Robert H. Lurie Children's Hospital of Chicago
RECRUITING
Chicago
Other Locations
Argentina
Helios Salud S.A
RECRUITING
Buenos Aires
Italy
ASST FBF Sacco Ospedale Sacco
RECRUITING
Milan
IRCCS Ospedale Pediatrico Bambino Gesu, UOS Infezioni Complesse e Perinatali
RECRUITING
Roma
South Africa
Be Part Yoluntu
RECRUITING
Cape Town
FAMCRU Ukwanda School for Rural Health
ACTIVE_NOT_RECRUITING
Cape Town
Durban International Clinical Research Site, Enhancing Care Foundation
RECRUITING
Durban
Nkanyezi VIDA Research Unit
RECRUITING
Johannesburg
Perinatal HIV Research Unit
RECRUITING
Johannesburg
Wits RHI Shandukani Research Centre CRS
RECRUITING
Johannesburg
Clinical Research Institute of South Africa (CRISA)
RECRUITING
Kwadukuza
The Aurum Institute: Pretoria Clinical Research Centre
RECRUITING
Pretoria
Setshaba Research Centre
ACTIVE_NOT_RECRUITING
Soshanguve
Spain
Hospital General Universitario Gregorio Marano
RECRUITING
Madrid
Hospital Universitario 12 De Octubre
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
Contact Information
Primary
Gilead Clinical Study Information Center
GileadClinicalTrials@gilead.com
1-833-445-3230 (GILEAD-0)
Time Frame
Start Date: 2024-11-20
Estimated Completion Date: 2028-08
Participants
Target number of participants: 75
Treatments
Experimental: Cohort 1: Participants Aged ≥ 12 to < 18 years with Weight ≥ 35 kg: BIC/LEN 75/50 mg FDC
Participants will receive a 2-day oral loading dose of LEN (600 mg) on Days 1 and 2 and daily oral BIC/LEN 75/50 mg starting on Day 1 through Week 48.~Following Week 48, participants will have an option to continue BIC/LEN in the extension period.
Experimental: Cohort 2: Participants Aged ≥ 6 to < 12 years with Weight ≥ 25 kg to < 35 kg
All participants will receive a 2-day oral loading dose of LEN, and daily oral BIC and LEN dose starting on Day 1 through Week 48. Dose in cohort 2 to be defined.~Following Week 48, participants will have an option to continue BIC/LEN in the extension period.
Experimental: Cohort 3: Participants Aged ≥ 2 to < 6 years with Weight ≥ 10 kg to < 25 kg
All participants will receive a 2-day oral loading dose of LEN, and daily oral BIC and LEN dose starting on Day 1 through Week 48. Dose in cohort 3 to be defined.~Following Week 48, participants will have an option to continue BIC/LEN in the extension period.
Related Therapeutic Areas
Sponsors
Leads: Gilead Sciences

This content was sourced from clinicaltrials.gov

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