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

Purpose

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.

Condition

HIV-1-infection

Eligibility

Eligible Ages: Between 2 Years and 17 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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.

Study Design

Phase: Phase 2/Phase 3
Study Type: Interventional
Allocation: N/A
Intervention Model: Sequential Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
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.	Drug: Lenacapavir Tablets administered orally without regard to food Other names: GS-6207 Drug: BIC/LEN FDC Tablets administered orally without regard to food
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.	Drug: Lenacapavir Tablets administered orally without regard to food Other names: GS-6207 Drug: BIC/LEN FDC Tablets administered orally without regard to food
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.	Drug: Lenacapavir Tablets administered orally without regard to food Other names: GS-6207 Drug: BIC/LEN FDC Tablets administered orally without regard to food

Recruiting Locations

Children's National Hospital
Washington D.C. 4140963, District of Columbia 4138106 20010

University of South Florida
Tampa 4174757, Florida 4155751 33612

Grady Ponce de Leon Center
Atlanta 4180439, Georgia 4197000 30308

Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago 4887398, Illinois 4896861 60614

More Details

NCT ID: NCT06532656
Status: Recruiting
Sponsor: Gilead Sciences

Study Contact

Gilead Clinical Study Information Center
1-833-445-3230 (GILEAD-0)
GileadClinicalTrials@gilead.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.