Status:
RECRUITING
Study of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1
Lead Sponsor:
Gilead Sciences
Conditions:
HIV-1-infection
Eligibility:
All Genders
2-17 years
Phase:
PHASE2
PHASE3
Brief Summary
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 (...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
November 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06532656
Start Date
November 20 2024
End Date
August 1 2028
Last Update
October 30 2025
Active Locations (20)
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1
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010
2
University of South Florida
Tampa, Florida, United States, 33612
3
Grady Ponce de Leon Center
Atlanta, Georgia, United States, 30308
4
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60614