A Study of the Safety, Tolerability, and Pharmacokinetics of Dolutegravir in Neonates Exposed to … (NCT05406583) | Clinical Trial Compass
CompletedPhase 1
A Study of the Safety, Tolerability, and Pharmacokinetics of Dolutegravir in Neonates Exposed to HIV-1
United States, South Africa, Thailand96 participantsStarted 2022-10-05
Plain-language summary
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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
. At entry, infant meets DTG exposure requirements, based on mother's report and confirmed by medical records if available, as follows:
. Infant was singleton with a gestational age at birth of at least 37 weeks.
. At birth, infant's weight was as follows:
. At screening, infant has the following laboratory test results, based on severity grading specified in the protocol section 7.3.3:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of Infants Classified as Study Drug-related Safety Failures Through 2 Weeks After DTG-Discontinuation.
Timeframe: Initial study drug dosing through 2 weeks after off treatment date (after treatment discontinuation), up to 5 weeks for Cohort 1 and up to 8 weeks for Cohort 2
2
Proportion of Infants Classified as Safety Failures Through 2 Weeks After DTG-Discontinuation.
Timeframe: Initial study drug dosing through 2 weeks after off treatment date (after treatment discontinuation), up to 5 weeks for Cohort 1 and up to 8 weeks for Cohort 2
3
Proportion of Infants Who Are Not Able to Tolerate the Study Drug.
Timeframe: Initial study drug dosing through study drug discontinuation, up to 3 weeks for Cohort 1 and up to 8 weeks for Cohort 2
4
DTG Ctrough for Cohort 1
Timeframe: Entry visit intensive PK sampling (0-5 days of life): pre-dose, and 1-2, 4-8, 11-13, 22-26 and 48-72 hours post-dose; 7 Days (+3 days) Post Initial Dose intensive PK sampling: pre-dose, and 1-2, 22-26 hours post-dose
5
DTG AUC0-48 for Cohort 1 at Entry Visit
Timeframe: Entry visit intensive PK sampling (0-5 days of life): pre-dose, and 1-2, 4-8, 11-13, 22-26 and 48-72 hours post-dose
6
Trial details
NCT IDNCT05406583
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. 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).
Exclusion criteria
. 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.
DTG AUC0-24 for Cohort 1 at 7 Days (+3 Days) Post Initial Dose Visit
Timeframe: 7 days (+3 days) post initial dose intensive PK sampling: pre-dose, and 1-2, 22-26 hours post-dose
7
DTG Ctrough for Cohort 2 at 7 Days (+3 Days) Post Initial Dose Visit
Timeframe: 7 days (+3 days) post initial dose PK sampling: pre-dose, and 1-2, 6-10, 22-26 hours post-dose, and prior to the next dose (for infants continuing to receive DTG every 48 hours)
8
DTG Ctrough for Cohort 2 at Week 4
Timeframe: Week 4 intensive PK sampling (22-33 days of life): pre-dose, and 1-2, 6-10, 22-26 hours post-dose
9
DTG AUC(0-tau) for Cohort 2 at 7 Days (+3 Days) Post Initial Dose Visit
Timeframe: 7 days (+3 days) post initial dose PK sampling: pre-dose, and 1-2, 6-10, 22-26 hours post-dose, and prior to the next dose (for infants continuing to receive DTG every 48 hours)
10
DTG AUC(0-tau) for Cohort 2 at Week 4 Visit
Timeframe: Week 4 intensive PK sampling (22-33 days of life): pre-dose, and 1-2, 6-10, 22-26 hours post-dose