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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-509428-16 | Other Identifier | European Medicines Agency |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Participants Aged ≥ 12 to < 18 years with Weight ≥ 35 kg: BIC/LEN 75/50 mg FDC | Experimental | 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. |
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| Cohort 2: Participants Aged ≥ 6 to < 12 years with Weight ≥ 25 kg to < 35 kg | Experimental | 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. |
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| Cohort 3: Participants Aged ≥ 2 to < 6 years with Weight ≥ 10 kg to < 25 kg | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenacapavir | Drug | Tablets administered orally without regard to food |
|
| Measure | Description | Time Frame |
|---|---|---|
| PK Parameter: Cmax of BIC and LEN at Steady State | Cmax is defined as the maximum observed concentration of drug at steady state. | Day 1 up to Week 24, as appropriate |
| 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. | Day 1 up to Week 24, as appropriate |
| 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. | Day 1 up to Week 24, as appropriate |
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) Through Week 24 | First dose date up to Week 24 | |
| Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Through Week 24 | First dose date up to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 up to Week 48, as appropriate |
| PK Parameter: Tmax for BIC and LEN at Steady State |
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Key Inclusion Criteria:
Age and body weight at screening:
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:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's National Hospital | Washington D.C. | District of Columbia | 20010 | United States | ||
| University of South Florida |
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| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
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|
| BIC/LEN FDC | Drug | Tablets administered orally without regard to food |
|
Tmax is defined as the time (observed time point) of Cmax at steady state. |
| Day 1 up to Week 48, as appropriate |
| 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). | Day 1 up to Week 48, as appropriate |
| PK Parameter: T1/2 for BIC and LEN at Steady State | T1/2 is defined as the terminal elimination half-life at steady state. | Day 1 up to Week 48, as appropriate |
| 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. | Day 1 up to Week 48, as appropriate |
| 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. | Day 1 up to Week 48, as appropriate |
| 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. | Day 1 up to Week 48, as appropriate |
| Percentage of Participants Experiencing TEAEs Through Week 48 | First dose date up to Week 48 |
| Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Through Week 48 | First does date up to Week 48 |
| 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 | Week 24 |
| 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 | Week 48 |
| Change from Baseline in Clusters of Differentiation 4 (CD4) Cell Counts at Week 24 | Baseline, Week 24 |
| Change from Baseline in CD4 Percentage at Week 24 | Baseline, Week 24 |
| Change from Baseline in CD4 Cell Counts at Week 48 | Baseline, Week 48 |
| Change from Baseline in CD4 Percentage at Week 48 | Baseline, Week 48 |
| 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. | Day 1 |
| 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. | Day 2 |
| 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. | Day 1 |
| 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. | Week 4 |
| 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. | Week 24 |
| 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. | Week 48 |
| Tampa |
| Florida |
| 33612 |
| United States |
| Grady Ponce de Leon Center | Atlanta | Georgia | 30308 | United States |
| Ann and Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60614 | United States |
| Helios Salud S.A | Buenos Aires | C1141ACG, | Argentina |
| ASST FBF Sacco Ospedale Sacco | Milan | 20157 | Italy |
| IRCCS Ospedale Pediatrico Bambino Gesu, UOS Infezioni Complesse e Perinatali | Roma | 00165 | Italy |
| FAMCRU Ukwanda School for Rural Health | Cape Town | 7505 | South Africa |
| Be Part Yoluntu | Cape Town | 7646 | South Africa |
| Durban International Clinical Research Site, Enhancing Care Foundation | Durban | 3629 | South Africa |
| Monti Clinical Research Centre | East London | 5219 | South Africa |
| Perinatal HIV Research Unit | Johannesburg | 1862 | South Africa |
| Wits RHI Shandukani Research Centre CRS | Johannesburg | 2038 | South Africa |
| Nkanyezi VIDA Research Unit | Johannesburg | 2112 | South Africa |
| Khomanani Health Research and Wellness Centre | Ka-Majosi | 944 | South Africa |
| Clinical Research Institute of South Africa (CRISA) | KwaDukuza | 4449 | South Africa |
| The Aurum Institute: Pretoria Clinical Research Centre | Pretoria | 0087 | South Africa |
| Setshaba Research Centre | Soshanguve | 0152 | South Africa |
| Hospital General Universitario Gregorio Marano | Madrid | 28007 | Spain |
| Hospital Universitario 12 De Octubre | Madrid | 28041 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| ID | Term |
|---|---|
| C000730993 | lenacapavir |
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