Evaluating the Safety and Pharmacokinetics of Raltegravir in Infants
Public ClinicalTrials.gov record NCT01828073. 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
Raltegravir Pharmacokinetics and Safety in Neonates
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study was to determine the washout pharmacokinetics (PK) and safety of in utero/intrapartum exposure to maternal raltegravir (RAL) in infants born to pregnant women with HIV infection who received RAL 400 mg twice daily. The study also provided data for the development of an infant RAL starting dosing regimen for IMPAACT P1110 (NCT01780831).
Study identification
- NCT ID
- NCT01828073
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 40 participants
Conditions and interventions
Conditions
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
- May 18, 2011
- Primary completion
- Apr 22, 2018
- Completion
- Apr 22, 2018
- Last update posted
- Nov 7, 2021
2011 – 2018
United States locations
- U.S. sites
- 12
- U.S. states
- 7
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California, UC San Diego CRS- Mother-Child-Adolescent HIV Program | La Jolla | California | 92093-0672 | — |
| Miller Children's Hosp. Long Beach CA NICHD CRS | Long Beach | California | 90806 | — |
| Usc La Nichd Crs | Los Angeles | California | 90089 | — |
| David Geffen School of Medicine at UCLA NICHD CRS | Los Angeles | California | 90095-1752 | — |
| Univ. of California San Francisco NICHD CRS | San Francisco | California | 94143 | — |
| Univ. of Florida Jacksonville NICHD CRS | Jacksonville | Florida | 32209 | — |
| Johns Hopkins Univ. Baltimore NICHD CRS | Baltimore | Maryland | 21287 | — |
| Boston Medical Center Ped. HIV Program NICHD CRS | Boston | Massachusetts | 02118 | — |
| Bronx-Lebanon Hospital Center NICHD CRS | The Bronx | New York | 10457 | — |
| Jacobi Med. Ctr. Bronx NICHD CRS | The Bronx | New York | 10461 | — |
| St. Jude Children's Research Hospital CRS | Memphis | Tennessee | 38105-3678 | — |
| Seattle Children's Research Institute CRS | Seattle | Washington | 98101 | — |
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 NCT01828073, 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 Nov 7, 2021 · Synced Sep 25, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01828073 live on ClinicalTrials.gov.