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

Completed · Phase 1/Phase 2

Conditions studied: HIV Infections

In brief

The purpose of this study was to examine the pharmacokinetics, safety, and tolerability of abacavir/dolutegravir/lamivudine dispersible and immediate release tablets in children living with HIV less than 12 years of age.

Key facts

Study ID

NCT03760458

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

57

Starts

2020-09-09

Expected to finish

2022-05-31

Last updated by the study team

2023-06-27

Who can join

Age: any, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)*

You may not qualify if…

• Documented resistance to ABC, DTG, or 3TC
• Note: Testing to rule out resistance is not required, and the M184V resistance mutation is not exclusionary.
• For ART-experienced children (on a stable ART regimen), documented HIV-1 RNA result greater than or equal to 200 copies/mL based on a specimen collected within six months prior to entry
• History of any of the following as determined by the site investigator based on participant/parent/guardian report and available medical records:
• Malignancy (ever)
• Hypersensitivity reaction to ABC (ever)
• Receipt of any prohibited medication (refer to the study protocol for more information) within 30 days prior to study entry
• Receipt of systemic interferon or any chronic systemic immunosuppressant medication within 30 days prior to study entry
• Note: Systemic corticosteroids (e.g., prednisone or equivalent up to 2 mg/kg) taken for replacement or short course therapy are permitted. Intranasal or inhaled steroid use is also permitted.
• Has any of the following as determined by the site investigator based on participant/parent/guardian report and available medical records
• Current clinical evidence of pancreatitis
• Currently-active tuberculosis (TB) and/or currently receiving rifampicin-containing TB treatment
• Currently-active AIDS-defining (WHO Clinical Stage 4) opportunistic infection
• Has any documented or suspected clinically significant medical condition or any other condition that, in the opinion of the site investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives

Where it is running

• David Geffen School of Medicine at UCLA NICHD CRS — Los Angeles, California, United States
• Univ. of Colorado Denver NICHD CRS — Aurora, Colorado, United States
• Rush Univ. Cook County Hosp. Chicago NICHD CRS — Chicago, Illinois, United States
• Lurie Children's Hospital of Chicago (LCH) CRS — Chicago, Illinois, United States
• St. Jude Children's Research Hospital CRS — Memphis, Tennessee, United States
• Gaborone CRS — Gaborone, Botswana
• Molepolole CRS — Gaborone, Botswana
• Soweto IMPAACT CRS — Johannesburg, Gauteng, South Africa
• Wits RHI Shandukani Research Centre CRS — Johannesburg, Gauteng, South Africa
• Umlazi CRS — Umlazi, KwaZulu-Natal, South Africa
• Famcru Crs — Tygerberg, Western Cape, South Africa
• Siriraj Hospital, Mahidol University NICHD CRS — Bangkok, Bangkoknoi, Thailand
• Chiangrai Prachanukroh Hospital NICHD CRS — Changklan, Muang, Chiang Mai, Thailand
• Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS — Chiang Mai, Thailand

Full record on ClinicalTrials.gov

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