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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05406583
The ClinicalTrials.gov registry entry for NCT05406583 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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