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HIV-1-infectionPhase 2/3NCT06532656

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

A Phase 2/3 study testing Lenacapavir, Bictegravir/Lenacapavir (BIC/LEN) FDC and Bictegravir/Lenacapavir in people with HIV-1-infection, run by Gilead Sciences at 21 sites in 5 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this clinical study is to learn about the safety and tolerability of bictegravir (BIC)/lenacapavir (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… Read more about this study

Who is it for?
Ages 2 to 17 years
Conditions the study is for
HIV-1-infection
What is being tested?
Lenacapavir, Bictegravir/Lenacapavir (BIC/LEN) FDC and Bictegravir/Lenacapavir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
21 sitesin 5 countries
Study dates
20 Nov 2024to Dec 2030
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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).
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  • 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).

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

21 sites in 5 countries.

21 sites in 5 countries

South Africa11 sites

  • FAMCRU Ukwanda School for Rural Health

    Cape Town, 7505

  • Be Part Yoluntu

    Cape Town, 7646

  • Durban International Clinical Research Site, Enhancing Care Foundation

    Durban, 3629

  • Monti Clinical Research Centre

    East London, 5219

  • Perinatal HIV Research Unit

    Johannesburg, 1862

  • Wits RHI Shandukani Research Centre CRS

    Johannesburg, 2038

  • Nkanyezi VIDA Research Unit

    Johannesburg, 2112

  • Khomanani Health Research and Wellness Centre

    Ka-Majosi, 944

  • Clinical Research Institute of South Africa (CRISA)

    KwaDukuza, 4449

  • The Aurum Institute: Pretoria Clinical Research Centre

    Pretoria, 0087

  • Setshaba Research Centre

    Soshanguve, 0152

Other trials in South Africa

United States4 sites

  • Grady Ponce de Leon Center

    Atlanta, Georgia, 30308

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

    Chicago, Illinois, 60614

  • University of South Florida

    Tampa, Florida, 33612

  • Children's National Hospital

    Washington D.C., District of Columbia, 20010

Other trials in United States

Spain3 sites

  • Hospital General Universitario Gregorio Marano

    Madrid, 28007

  • Hospital Universitario 12 De Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

Other trials in Spain

Italy2 sites

  • ASST FBF Sacco Ospedale Sacco

    Milan, 20157

  • IRCCS Ospedale Pediatrico Bambino Gesu, UOS Infezioni Complesse e Perinatali

    Roma, 00165

Other trials in Italy

Argentina1 site

  • Helios Salud S.A

    Buenos Aires, C1141ACG,

Other trials in Argentina

About this study

Official 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

The goal of this clinical study is to learn about the safety and tolerability of bictegravir (BIC)/lenacapavir (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
Being tested
Lenacapavir, Bictegravir/Lenacapavir (BIC/LEN) FDC, Bictegravir/Lenacapavir

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LenacapavirDrug

    Also called GS-6207

    Tablets administered orally without regard to food

  • Bictegravir/Lenacapavir (BIC/LEN) FDCDrug

    Also called Bixlenvo™

    Tablets administered orally without regard to food

  • Bictegravir/LenacapavirDrug

    Tablets administered orally without regard to food

Study groups in NCT06532656
Study groupRoleWhat they receive
Cohort 1: Participants Aged ≥ 12 to < 18 years with Weight ≥ 35 kg: BIC/LEN TOS 75/50 mg FDCExperimentalParticipants will receive a 2-day oral loading dose of LEN (600 mg) on Days 1 and 2 and daily oral BIC/LEN TOS 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.
Receives: Drug: Lenacapavir; Drug: Bictegravir/Lenacapavir (BIC/LEN) FDC
Cohort 2: Participants Aged ≥ 6 to < 12 years with Weight ≥ 25 kg to < 35 kgExperimentalAll 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.
Receives: Drug: Lenacapavir; Drug: Bictegravir/Lenacapavir
Cohort 3: Participants Aged ≥ 2 to < 6 years with Weight ≥ 10 kg to < 25 kgExperimentalAll 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.
Receives: Drug: Lenacapavir; Drug: Bictegravir/Lenacapavir

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: Day 1 up to Week 24, as appropriate

  2. 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.

    Measured: Day 1 up to Week 24, as appropriate

  3. 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.

    Measured: Day 1 up to Week 24, as appropriate

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

    Measured: First dose date up to Week 24

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

    Measured: First dose date up to Week 24

Secondary outcomes (21)

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

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

    Measured: Day 1 up to Week 48, as appropriate

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

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

    Measured: Day 1 up to Week 48, as appropriate

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

    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).

    Measured: Day 1 up to Week 48, as appropriate

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

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

    Measured: Day 1 up to Week 48, as appropriate

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

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

    Measured: Day 1 up to Week 48, as appropriate

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

    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.

    Measured: Day 1 up to Week 48, as appropriate

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

    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.

    Measured: Day 1 up to Week 48, as appropriate

  8. Percentage of Participants Experiencing TEAEs Through Week 48

    Measured: First dose date up to Week 48

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

    Measured: 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

    Measured: 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

    Measured: Week 48

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

    Measured: Baseline, Week 24

  13. Change from Baseline in CD4 Percentage at Week 24

    Measured: Baseline, Week 24

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

    Measured: Baseline, Week 48

  15. Change from Baseline in CD4 Percentage at Week 48

    Measured: Baseline, Week 48

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

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

    Measured: Day 1

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

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

    Measured: Day 2

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

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

    Measured: Day 1

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

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

    Measured: Week 4

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

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

    Measured: Week 24

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

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

    Measured: Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2024
  2. Study start20 Nov 2024
  3. Primary completionJul 2030 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06532656
Sponsor's protocol ID
GS-US-621-6463
Other IDs
2023-509428-16, 2023
Status last verified
Sep 2026
First submitted
29 Jul 2024
Last updated
29 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Lenacapavir, Bictegravir/Lenacapavir (BIC/LEN) FDC and Bictegravir/Lenacapavir in people with HIV-1-infection, run by Gilead Sciences at 21 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in South Africa, United States, Spain, Italy, Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PK Parameter: Cmax of BIC and LEN at Steady State (time frame: Day 1 up to Week 24, as appropriate). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06532656.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.

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