Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT06532656
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
17 Years
Study:
NCT06532656
Study Brief:
Protocol Section:
NCT06532656