A Study of the Safety, Tolerability, and Pharmacokinetics of Dolutegravir in Neonates Exposed to HIV-1
Public ClinicalTrials.gov record NCT05406583. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase I Study of the Safety, Tolerability, and Pharmacokinetics of Dolutegravir in Neonates Exposed to HIV-1
Study identification
- NCT ID
- NCT05406583
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- NIH
- Enrollment
- 48 participants
Conditions and interventions
Conditions
Interventions
- Dolutegravir 0.5 mg/kg oral suspension Drug
- Dolutegravir 5 mg Dispersible Tablets Drug
Drug
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 4, 2022
- Primary completion
- Mar 11, 2025
- Completion
- May 21, 2025
- Last update posted
- Aug 28, 2025
2022 – 2025
United States locations
- U.S. sites
- 8
- U.S. states
- 7
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| USC - Maternal Child Adolescent/Adult Center | Los Angeles | California | 90033-1075 | — |
| David Geffen School of Medicine at UCLA NICHD CRS | Los Angeles | California | 90095-1752 | — |
| University of Colorado Denver NICHD CRS | Aurora | Colorado | 80045 | — |
| Emory University School of Medicine NICHD CRS | Atlanta | Georgia | 30322 | — |
| Rush University, Cook County Hospital NICHD CRS | Chicago | Illinois | 60612 | — |
| Bronx-Lebanon Hospital Center NICHD CRS | The Bronx | New York | 10457 | — |
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105-3678 | — |
| Baylor College of Medicine/ Texas Children's Hospital NICHD CRS | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05406583, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 28, 2025 · Synced May 20, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05406583 live on ClinicalTrials.gov.