The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age

Inclusion Criteria

• Weight 6 kg to less than 40 kg at entry
• Antiretroviral therapy (ART)-naïve at entry or has been taking a stable ART regimen for at least six consecutive months at entry
• Note: For ART-naïve children, receipt of antiretroviral (ARV) prophylaxis prior to diagnosis of HIV infection is permitted. For these children, ascertainment of this criterion may be based on parent or guardian report only, but available medical records should also be reviewed in relation to this criterion.
• Note: For ART-experienced children (on a stable ART regimen), dose and formulation changes (e.g., for growth) within the six months prior to entry are permitted. For these children, ascertainment of this criterion must be based on medical records.
• For ART-experienced children (on a stable ART regimen), has had a suppressed HIV viral load (HIV-1 RNA less than 200 copies/mL) for at least six consecutive months prior to entry
• Note: To fulfill this criterion, at least two documented HIV-1 RNA results less than 200 copies/mL must be available, one based on a specimen collected at least six months prior to entry and one based on a specimen collected within 30 days prior to entry.
• Note: Any documented HIV-1 RNA result greater than or equal to 200 copies/mL based on a specimen collected within six months prior to entry is exclusionary (see exclusion criterion below).
• At screening, has normal, Grade 1, or Grade 2 laboratory test results for all of the following, based on testing of specimens collected within 30 days prior to entry and grading per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (refer to the study protocol for guidance on severity grading):
• Hemoglobin (greater than or equal to 8.5 g/dL or greater than or equal to 5.25 mmol/L)
• Absolute neutrophil count (greater than or equal to 600 cells/mm^3 or greater than or equal to 0.600 x 10^9 cells/L)
• Platelet count (greater than or equal to 50,000 cells/mm^3 or greater than or equal to 50.00 x 10^9 cells/L)
• Estimated glomerular filtration rate (eGFR; bedside Schwartz formula; greater than or equal to 60 ml/min/1.73 m^2)
• Alanine transaminase (ALT) (less than 5.0 x ULN)
• Aspartate aminotransferase (AST) (less than 5.0 x ULN)
• Total bilirubin (less than 2.6 x ULN)
• Direct bilirubin (less than or equal to ULN)
• Note: Laboratory tests may be repeated during the screening period (i.e., within 30 days prior to entry), with the latest results used for eligibility determination.
• Note: For treatment-experienced children on an atazanavir-containing ART regimen, Grade 3 or higher total bilirubin is permitted.
• At screening, has a negative test result for hepatitis B surface antigen based on testing of a specimen collected within 30 days prior to entry
• Confirmed HIV-1-infection based on documented testing of two samples collected at different time points:
• Sample #1 may be tested using any of the following:
• Two rapid antibody tests from different manufacturers or based on different principles and epitopes
• One enzyme immunoassay OR Western Blot OR immunofluorescence assay OR chemiluminescence assay
• One HIV DNA polymerase chain reaction (PCR)*
• One quantitative HIV RNA PCR (above the limit of detection of the assay)*
• One qualitative HIV RNA PCR*
• One HIV total nucleic acid test*
• Sample #2 may be tested using any of the following:
• Rapid antibody test. If this option is used in combination with two rapid tests for Sample #1, at least one of the three rapid tests must be United States Food and Drug Administration (FDA)-approved, and the third rapid test must be from a third manufacturer or based on a third principle or epitope.
• One enzyme immunoassay OR Western Blot OR immunofluorescence assay OR chemiluminescence assay
• One HIV DNA PCR*
• One quantitative HIV RNA PCR (above the limit of detection of the assay)*
• One qualitative HIV RNA PCR*
• One HIV total nucleic acid test*
• For participants who are less