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NCT06532656

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

Active, Not Recruiting
PHASE2Ages 2–17InterventionalTreatment
Gilead Sciences
~75 participants
Updated 2026-06-04 on ClinicalTrials.gov
What's tested:LenacapavirBIC/LEN FDC

At a glance

Recruiting sites
0 of 21 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
PK Parameter: Cmax of BIC and LEN at Steady State
Measured over Day 1 up to Week 24, as appropriate
+4 more outcomes measured

Conditions

HIV-1-infection

Explore related trials

HIV InfectionHIV Infection

Where it's being run

21 sites across 8 states
South Africa11
Spain3
Italy2
District of Columbia1
Florida1
Georgia1
Illinois1
Argentina1

Study leadership

  • Gilead Study Director · STUDY_DIRECTOR · Gilead Sciences

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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)
Total bilirubin ≤ 23 μmol/L (≤ 1.5 mg/dL) and direct bilirubin ≤ 7 μmol/L (≤ 0.4 mg/dL).

Exclusion

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.

What this trial measures

  • PK Parameter: Cmax of BIC and LEN at Steady StateDay 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 StateDay 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 StateDay 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 24First dose date up to Week 24
  • Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Through Week 24First dose date up to Week 24