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A Study of the Safety, Tolerability, and Pharmacokinetics of Dolutegravir in Neonates Exposed to HIV-1 | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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

NCT05406583•National Institute of Allergy and Infectious Diseases (NIAID)

View on ClinicalTrials.gov

Summary

This study will test an anti-HIV drug (ARV) for newborn babies. The study will include a minimum of 36 and up to 108 mothers living with HIV and their newborn babies from Brazil, South Africa, Thailand, and the United States. Infants will be in the study for approximately 16 weeks (four months) after they are born. Mothers will not receive study drug and will exit the study after the Entry visit.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 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.
•2. 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.
•3. 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.
•4. Infant was singleton with a gestational age at birth of at least 37 weeks.
•5. At birth, infant's weight was as follows:
+15 more criteria

Exclusion Criteria

•1. 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.
•2. Infant or breastfeeding mother is receiving any disallowed medication.
•3. At entry, infant with a documented positive HIV nucleic acid test result.
•4. Infants with prior exchange transfusion or with elevated bilirubin that would require exchange transfusion.
•5. 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.

Locations (15)

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 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

Key Dates

Start Date

October 5, 2022

Primary Completion Date

March 12, 2025

Completion Date

May 22, 2025

Last Updated

August 29, 2025

Enrollment

ACTUAL participants

Conditions

HIV

Interventions

Dolutegravir 0.5 mg/kg oral suspension

DRUG

Dolutegravir 5 mg Dispersible Tablets

DRUG

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

NCT04929028

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RECRUITING

Thinking and Memory Problems in People With HIV

NCT01875588

HIV Positive

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

Thinking and Memory Problems in People With HIV

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