A Study of the Safety, Tolerability, and Pharmacokinetics of Dolutegravir in Neonates Exposed to HIV-1

Completed · Phase 1

Conditions studied: HIV

In brief

The purpose of this study was to evaluate the safety, tolerability, and pharmacokinetics (PK) of dolutegravir (DTG) in infants born to mothers living with HIV-1. The primary goal of the study was to propose a dose of DTG that is safe and meets PK targets when administered to infants through the first four weeks of life in addition to the infant's standard HIV-1 ARV prophylaxis. The study was expected to enroll a minimum of 36 and up to 108 mother-infant (M-I) pairs from Brazil, South Africa, Thailand, and the United States. Infants were followed through 16 weeks of life. Mothers did not receive study drug and were off study after completion of the Entry visit. A total of 48 M-I pairs were enrolled in the study.

Key facts

Study ID

NCT05406583

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

96

Starts

2022-10-05

Expected to finish

2025-05-22

Last updated by the study team

2026-05-22

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Mother is of legal age or circumstance to provide independent informed consent and is willing and able to provide written informed consent for her and permission for her infant's participation in this study.
• Mother has confirmed HIV-1 infection based on positive test results from two samples collected from two separate blood collection tubes per Sample #1 and Sample #2 protocol requirements. Test results may be obtained from medical records or from testing performed during the study screening period:
• For results obtained from medical records, adequate source documentation, including the date of specimen collection, date of testing or date of test result, name of test/assay performed, and test result, must be available in study records prior to study entry. Requirements related to laboratory operations (e.g., CLIA, GCLP, or VQA) and related to regulatory authority (e.g., FDA) approvals do not apply to results obtained from medical records.
• If adequate source documentation is not available, Sample #1 and/or Sample #2 should be collected during the study screening period and tested in the site's designated testing laboratory. If both samples are tested using antibody tests, at least one of the samples must be tested in a laboratory that operates according to CLIA or equivalent (for US sites) or GCLP (for non-US sites) guidelines and participates in an appropriate external quality assurance program. If nucleic acid testing is used, at least one test must be performed in the site's CLIA-certified or equivalent (for US sites) or VQA-certified (for non-US sites) laboratory.
• All study-specific samples tested to determine HIV-1 status must be whole blood, serum, or plasma. HIV testing methods and algorithms must be approved for each site by the IMPAACT Laboratory Center (for NIAID-funded sites) or Westat (for NICHD-funded sites). All test methods should be FDA-approved, if available.
• At entry, infant meets DTG exposure requirements, based on mother's report and confirmed by medical records if available, as follows:
• For Cohort 1, Strata 1A and 1C, and Cohort 2, Stratum 2A: Infant born to a mother who did not receive DTG during the two weeks immediately prior to delivery.
• For Cohort 1, Stratum 1B, and Cohort 2, Stratum 2B: Infant born to a mother who received at least one dose of DTG less than or equal to 72 hours prior to delivery.
• Infant was singleton with a gestational age at birth of at least 37 weeks.
• At birth, infant's weight was as follows:
• For Cohort 1, Strata 1A,1B, 1C, and Cohort 2, Strata 2A and 2B: At least 2 kg
• At screening, infant has the following laboratory test results, based on severity grading specified in the protocol section 7.3.3:
• ALT (normal)
• AST (normal or Grade 1)
• Total bilirubin (normal or Grade 1)
• Hemoglobin (normal, Grade 1, or Grade 2)
• White blood cells (normal, Grade 1, or Grade 2)
• Platelets (normal, Grade 1, or Grade 2)
• Creatinine (normal, Grade 1, or Grade 2)
• At entry, infant is less than or equal to five days of life.
• At entry, infant has initiated standard of care ARV prophylaxis (i.e., received at least one dose of ARV regimen prior to entry).
• At entry, infant is generally healthy as determined by the site investigator based on review of all available medical history information and physical examination findings.

You may not qualify if…

• Known maternal-fetal blood group incompatibility as evidenced by the presence of an unexpected clinically significant maternal red blood cell antibody that is known to cause hemolytic disease of the fetus and newborn.
• Infant or breastfeeding mother is receiving any disallowed medicationlisted in protocol Section 5.8.1.
• At entry, infant with a documented positive HIV nucleic acid test result.
• Infants with prior exchange transfusion or with elevated bilirubin that would require exchange transfusion.
• Mother or infant has any condition that, in the opinion of the site investigator or designee, 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

• USC - Maternal Child Adolescent/Adult Center — Los Angeles, California, United States
• David Geffen School of Medicine at UCLA NICHD CRS — Los Angeles, California, United States
• University of Colorado Denver NICHD CRS — Aurora, Colorado, United States
• Emory University School of Medicine NICHD CRS — Atlanta, Georgia, United States
• Rush University, Cook County Hospital Chicago NICHD CRS — Chicago, Illinois, United States
• Bronx-Lebanon Hospital Center NICHD CRS — The Bronx, New York, United States
• St. Jude Children's Research Hospital — Memphis, Tennessee, United States
• Baylor College of Medicine/ Texas Children's Hospital NICHD CRS — Houston, Texas, United States
• Soweto — Johannesburg, Gauteng, South Africa
• Wits RHI Shandukani Research Centre CRS — Johannesburg, Gauteng, South Africa
• Umlazi — Durban, KwaZulu-Natal, South Africa
• FAMCRU — Cape Town, South Africa
• Siriraj Hospital, Mahidol University NICHD CRS — Bangkok, Thailand
• Chiang Mai University HIV Treatment — Chiang Mai, Thailand
• Chiangrai Prachanukroh Hospital NICHD CRS — Chiang Rai, Thailand

Full record on ClinicalTrials.gov

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