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

NCT06532656 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: GS-US-621-64632023-509428-16
• Study Type: interventional
• Target: 75
• Locations: 5 countries
• Sites: 21

Brief 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.

Conditions

HIV-1-infection

Outcome Measures

Primary Outcomes (5)

• PK Parameter: Cmax of BIC and LEN at Steady State

  Cmax is defined as the maximum observed concentration of drug at steady state.

  Day 1 up to Week 24, as appropriate

• PK Parameter: AUCtau of BIC and LEN at Steady State

  AUCtau is defined as the area under the concentration versus time curve over the dosing interval at steady state.

  Day 1 up to Week 24, as appropriate

• PK Parameter: Ctrough of BIC and LEN at Steady State

  Ctrough is defined as the observed drug concentration at the end of the dosing interval at steady state.

  Day 1 up to Week 24, as appropriate

• 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

Secondary Outcomes (21)

• PK Parameter: AUClast for BIC and LEN at Steady State

  Day 1 up to Week 48, as appropriate

• PK Parameter: Tmax for BIC and LEN at Steady State

  Day 1 up to Week 48, as appropriate

• PK Parameter: Tlast for BIC and LEN at Steady State

  Day 1 up to Week 48, as appropriate

• PK Parameter: T1/2 for BIC and LEN at Steady State

  Day 1 up to Week 48, as appropriate

• PK Parameter: CL for BIC and LEN at Steady State

  Day 1 up to Week 48, as appropriate

Study Arms (3)

Cohort 1: Participants Aged ≥ 12 to < 18 years with Weight ≥ 35 kg: BIC/LEN 75/50 mg FDC

EXPERIMENTAL

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; Drug: BIC/LEN FDC

Cohort 2: Participants Aged ≥ 6 to < 12 years with Weight ≥ 25 kg to < 35 kg

EXPERIMENTAL

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; Drug: BIC/LEN FDC

Cohort 3: Participants Aged ≥ 2 to < 6 years with Weight ≥ 10 kg to < 25 kg

EXPERIMENTAL

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; Drug: BIC/LEN FDC

Interventions

Lenacapavir DRUG

Tablets administered orally without regard to food

Also known as: GS-6207

Cohort 1: Participants Aged ≥ 12 to < 18 years with Weight ≥ 35 kg: BIC/LEN 75/50 mg FDC; Cohort 2: Participants Aged ≥ 6 to < 12 years with Weight ≥ 25 kg to < 35 kg; Cohort 3: Participants Aged ≥ 2 to < 6 years with Weight ≥ 10 kg to < 25 kg

BIC/LEN FDC DRUG

Tablets administered orally without regard to food

Cohort 1: Participants Aged ≥ 12 to < 18 years with Weight ≥ 35 kg: BIC/LEN 75/50 mg FDC; Cohort 2: Participants Aged ≥ 6 to < 12 years with Weight ≥ 25 kg to < 35 kg; Cohort 3: Participants Aged ≥ 2 to < 6 years with Weight ≥ 10 kg to < 25 kg

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (21)

Children's National Hospital

Washington D.C., District of Columbia, 20010, United States

RECRUITING

University of South Florida

Tampa, Florida, 33612, United States

RECRUITING

Grady Ponce de Leon Center

Atlanta, Georgia, 30308, United States

RECRUITING

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

Chicago, Illinois, 60614, United States

RECRUITING

Helios Salud S.A

Buenos Aires, C1141ACG,, Argentina

RECRUITING

ASST FBF Sacco Ospedale Sacco

Milan, 20157, Italy

RECRUITING

IRCCS Ospedale Pediatrico Bambino Gesu, UOS Infezioni Complesse e Perinatali

Roma, 00165, Italy

RECRUITING

FAMCRU Ukwanda School for Rural Health

Cape Town, 7505, South Africa

ACTIVE NOT RECRUITING

Be Part Yoluntu

Cape Town, 7646, South Africa

RECRUITING

Durban International Clinical Research Site, Enhancing Care Foundation

Durban, 3629, South Africa

RECRUITING

Monti Clinical Research Centre

East London, 5219, South Africa

RECRUITING

Perinatal HIV Research Unit

Johannesburg, 1862, South Africa

RECRUITING

Wits RHI Shandukani Research Centre CRS

Johannesburg, 2038, South Africa

RECRUITING

Nkanyezi VIDA Research Unit

Johannesburg, 2112, South Africa

RECRUITING

Khomanani Health Research and Wellness Centre

Ka-Majosi, 944, South Africa

RECRUITING

Clinical Research Institute of South Africa (CRISA)

KwaDukuza, 4449, South Africa

RECRUITING

The Aurum Institute: Pretoria Clinical Research Centre

Pretoria, 0087, South Africa

RECRUITING

Setshaba Research Centre

Soshanguve, 0152, South Africa

ACTIVE NOT RECRUITING

Hospital General Universitario Gregorio Marano

Madrid, 28007, Spain

RECRUITING

Hospital Universitario 12 De Octubre

Madrid, 28041, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, 28046, Spain

RECRUITING

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Interventions

lenacapavir

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Central Study Contacts

Gilead Clinical Study Information Center

CONTACT

1-833-445-3230 (GILEAD-0); GileadClinicalTrials@gilead.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 1, 2024
• Study Start: November 20, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (4); ZA (11); ES (3); IT (2); AR (1)