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Evaluating Bictegravir and Lenacapavir in Children and Adolescents with HIV-1

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

Phase2; Phase3 Interventional Gilead Sciences · NCT06532656

This study is testing a new combination of medications for children and teenagers with HIV-1 to see if it is safe and works well for them while they are already on treatment.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment75 (estimated)
Ages2 Years to 17 Years
SexAll
SponsorGilead Sciences Industry-sponsored
Locations21 sites (Washington D.C., District of Columbia and 20 other locations)
Trial IDNCT06532656 on ClinicalTrials.gov

What this trial studies

This clinical study aims to assess the safety and tolerability of bictegravir/lenacapavir (BIC/LEN) in children and adolescents who are virologically suppressed and currently on a complex antiretroviral regimen for HIV-1. The study will evaluate the pharmacokinetics of BIC and LEN, confirming the appropriate loading dose of LEN and the fixed-dose combination of BIC/LEN. Participants will be monitored for safety and tolerability over a 24-week period.

Who should consider this trial

Good fit: Ideal candidates include children and adolescents aged 2 to 17 years who are virologically suppressed and on a complex antiretroviral regimen.

Not a fit: Patients who are not on a complex antiretroviral regimen or have documented resistance to integrase strand transfer inhibitors may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer and more effective treatment option for children and adolescents living with HIV-1.

How similar studies have performed: Other studies have shown promise in using similar approaches for treating HIV-1, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Washington D.C., District of Columbia and 20 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions HIV-1-infection
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.