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NCT05406583 · ClinicalTrials.gov registry record · Phase 1
A Study of the Safety, Tolerability, and Pharmacokinetics of Dolutegravir in Neonates Exposed to HIV-1
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 96
- Enrollment target
NCT05406583: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT05406583 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 96 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05406583, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 96 participants
- Enrollment target
Study 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.
Primary Outcome
An infant is classified as a "study drug-related" safety failure for the primary safety study objective if any of the following occurred after the initial study drug dosing through two weeks after permanent discontinuation of the study drug (i.e., two weeks after off treatment date): * Grade 3 or 4 Adverse Event (AE) assessed as related to study drug, or * Death (Grade 5 AE) assessed as related to the study drug, or * Life-threatening AE assessed as related to study drug, or * AE assessed as re
Interventions
- DRUG Dolutegravir 0.5 mg/kg liquid suspension (starts at 0-5 days of life)
- DRUG Dolutegravir 5 mg Dispersible Tablets (single doses)
- DRUG Dolutegravir 5 mg Dispersible Tablets (chronic dose)
- DRUG Dolutegravir 0.5 mg/kg liquid suspension (starts at 2-5 days of life)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2022-10-05 |
| Est. Completion | 2025-05-22 |
| Phase | Phase 1 |
What the finished NCT05406583 record still lists
NCT05406583 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% higher).
The record links to 0 conditions, and to 4 interventions - of which Dolutegravir 0.5 mg/kg liquid suspension (starts at 0-5 days of life) is the first listed.
NCT05406583 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05406583 about?
NCT05406583 is a clinical study titled "A Study of the Safety, Tolerability, and Pharmacokinetics of Dolutegravir in Neonates Exposed to HIV-1". 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 firs...
What is the current status of trial NCT05406583?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 96 participants. The study started on 2022-10-05. Estimated completion is 2025-05-22.
What interventions are being tested in trial NCT05406583?
The interventions under investigation include: Dolutegravir 0.5 mg/kg liquid suspension (starts at 0-5 days of life) (DRUG), Dolutegravir 5 mg Dispersible Tablets (single doses) (DRUG), Dolutegravir 5 mg Dispersible Tablets (chronic dose) (DRUG), Dolutegravir 0.5 mg/kg liquid suspension (starts at 2-5 days of life) (DRUG).
Who is sponsoring clinical trial NCT05406583?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05406583's enrollment target sits among peer trials
96 600th of 2000 higher than 1,391 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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