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NCT Number: NCT06532656

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

HIV-1-infection

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Helios Salud S.A, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lenacapavir

Drug

Tablets administered orally without regard to food

Other names: GS-6207

BIC/LEN FDC

Drug

Tablets administered orally without regard to food

Primary outcomes

  1. PK Parameter: Cmax of BIC and LEN at Steady State

    Time frame: Day 1 up to Week 24, as appropriate

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

  2. PK Parameter: AUCtau of BIC and LEN at Steady State

    Time frame: 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.

  3. PK Parameter: Ctrough of BIC and LEN at Steady State

    Time frame: 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.

  4. Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) Through Week 24

    Time frame: First dose date up to Week 24

  5. Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Through Week 24

    Time frame: First dose date up to Week 24

Secondary outcomes

  1. PK Parameter: AUClast for BIC and LEN at Steady State

    Time frame: Day 1 up to Week 48, as appropriate

    AUClast is defined as the area under the concentration versus time curve from time zero to the last quantifiable concentration at steady state.

  2. PK Parameter: Tmax for BIC and LEN at Steady State

    Time frame: Day 1 up to Week 48, as appropriate

    Tmax is defined as the time (observed time point) of Cmax at steady state.

  3. PK Parameter: Tlast for BIC and LEN at Steady State

    Time frame: Day 1 up to Week 48, as appropriate

    Tlast is defined as the time (observed time point) of Clast at steady state. Clast is defined as the last measurable concentration (above the quantification limit).

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

    Time frame: Day 1 up to Week 48, as appropriate

    T1/2 is defined as the terminal elimination half-life at steady state.

  5. PK Parameter: CL for BIC and LEN at Steady State

    Time frame: Day 1 up to Week 48, as appropriate

    Clearance (CL) is the volume of plasma cleared of drug over a specified time period, at a steady state.

  6. PK Parameter: Vz for BIC and LEN at Steady State

    Time frame: Day 1 up to Week 48, as appropriate

    Volume of distribution (Vz) is defined as the extent to in which the drug is distributed in the body tissue, rather than the plasma, to produce the desired effects at a steady state.

  7. PK Parameter: λz for BIC and LEN at Steady State

    Time frame: Day 1 up to Week 48, as appropriate

    λz is defined as the terminal elimination rate constant, which determines the rate at which the drug will be eliminated from the body after it is absorbed and distributed at a steady state.

  8. Percentage of Participants Experiencing TEAEs Through Week 48

    Time frame: First dose date up to Week 48

  9. Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Through Week 48

    Time frame: First does date up to Week 48

  10. Proportion of Participants With Plasma HIV-1 RNA < 50 copies/mL and ≥ 50 copies/mL at Week 24 Based on the United States (US) Food and Drug Administration (FDA)-Defined Snapshot Algorithm

    Time frame: Week 24

  11. Proportion of Participants With Plasma HIV-1 RNA < 50 copies/mL and ≥ 50 copies/mL at Week 48 Based on the United States FDA-Defined Snapshot Algorithm

    Time frame: Week 48

  12. Change from Baseline in Clusters of Differentiation 4 (CD4) Cell Counts at Week 24

    Time frame: Baseline, Week 24

  13. Change from Baseline in CD4 Percentage at Week 24

    Time frame: Baseline, Week 24

  14. Change from Baseline in CD4 Cell Counts at Week 48

    Time frame: Baseline, Week 48

  15. Change from Baseline in CD4 Percentage at Week 48

    Time frame: Baseline, Week 48

  16. Acceptability and Palatability Summary of LEN Oral Loading Dose at Day 1 Assessed by Questionnaire

    Time frame: Day 1

    Palatability and acceptability assessed by a numeric response between numbers 1-5. Higher scores indicate better palatability and acceptability.

  17. Acceptability and Palatability Summary of LEN Oral Loading Dose at Day 2 Assessed by Questionnaire

    Time frame: Day 2

    Palatability and acceptability assessed by a numeric response between numbers 1-5. Higher scores indicate better palatability and acceptability.

  18. Acceptability and Palatability Summary of Oral BIC/LEN Fixed Dose Combination (FDC) at Day 1 Assessed by Questionnaire

    Time frame: Day 1

    Palatability and acceptability assessed by a numeric response between numbers 1-5. Higher scores indicate better palatability and acceptability.

  19. Acceptability and Palatability Summary of Oral BIC/LEN FDC at Week 4 Assessed by Questionnaire

    Time frame: Week 4

    Palatability and acceptability assessed by a numeric response between numbers 1-5. Higher scores indicate better palatability and acceptability.

  20. Acceptability and Palatability Summary of Oral BIC/LEN FDC at Week 24 Assessed by Questionnaire

    Time frame: Week 24

    Palatability and acceptability assessed by a numeric response between numbers 1-5. Higher scores indicate better palatability and acceptability.

  21. Acceptability and Palatability Summary of Oral BIC/LEN FDC at Week 48 Assessed by Questionnaire

    Time frame: Week 48

    Palatability and acceptability assessed by a numeric response between numbers 1-5. Higher scores indicate better palatability and acceptability.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Aug 1, 2024
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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