Study of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1
NCT ID: NCT06532656
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
75 participants
INTERVENTIONAL
2024-11-20
2028-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohort 1: Participants Aged ≥ 12 to < 18 years with Weight ≥ 35 kg: BIC/LEN 75/50 mg FDC
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.
Lenacapavir
Tablets administered orally without regard to food
BIC/LEN FDC
Tablets administered orally without regard to food
Cohort 2: Participants Aged ≥ 6 to < 12 years with Weight ≥ 25 kg to < 35 kg
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.
Lenacapavir
Tablets administered orally without regard to food
BIC/LEN FDC
Tablets administered orally without regard to food
Cohort 3: Participants Aged ≥ 2 to < 6 years with Weight ≥ 10 kg to < 25 kg
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.
Lenacapavir
Tablets administered orally without regard to food
BIC/LEN FDC
Tablets administered orally without regard to food
Interventions
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Lenacapavir
Tablets administered orally without regard to food
BIC/LEN FDC
Tablets administered orally without regard to food
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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.
2 Years
17 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Children's National Hospital
Washington D.C., District of Columbia, United States
University of South Florida
Tampa, Florida, United States
Grady Ponce de Leon Center
Atlanta, Georgia, United States
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Helios Salud S.A
Buenos Aires, , Argentina
ASST FBF Sacco Ospedale Sacco
Milan, , Italy
IRCCS Ospedale Pediatrico Bambino Gesu, UOS Infezioni Complesse e Perinatali
Roma, , Italy
FAMCRU Ukwanda School for Rural Health
Cape Town, , South Africa
Be Part Yoluntu
Cape Town, , South Africa
Durban International Clinical Research Site, Enhancing Care Foundation
Durban, , South Africa
Monti Clinical Research Centre
East London, , South Africa
Perinatal HIV Research Unit
Johannesburg, , South Africa
Wits RHI Shandukani Research Centre CRS
Johannesburg, , South Africa
Nkanyezi VIDA Research Unit
Johannesburg, , South Africa
Khomanani Health Research and Wellness Centre
Ka-Majosi, , South Africa
Clinical Research Institute of South Africa (CRISA)
KwaDukuza, , South Africa
The Aurum Institute: Pretoria Clinical Research Centre
Pretoria, , South Africa
Setshaba Research Centre
Soshanguve, , South Africa
Hospital General Universitario Gregorio Marano
Madrid, , Spain
Hospital Universitario 12 De Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Countries
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Central Contacts
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Related Links
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Gilead Clinical Trials Website
Other Identifiers
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2023-509428-16
Identifier Type: OTHER
Identifier Source: secondary_id
GS-US-621-6463
Identifier Type: -
Identifier Source: org_study_id
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