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NCT01780831 · ClinicalTrials.gov registry record · Phase 1
Safety and Pharmacokinetics of Raltegravir in HIV-1-Exposed Newborn Infants at Risk of Acquiring HIV-1 Infection
A Phase 1 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
- 15
- Study locations
NCT01780831: Completed Phase 1 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01780831 is a Phase 1 study of HIV Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 52 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (88% lower). The trial reports 15 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01780831, a Phase 1 study of HIV Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
- 15
- Study locations
Study Summary
The purpose of this study was to evaluate the safety and pharmacokinetics (PK) of raltegravir (RAL) when given to HIV-1-exposed, normal birth weight newborn infants at risk of acquiring HIV-1 infection. (PK is the study of the time course of absorption, distribution, metabolism, and excretion of drugs in the body.) The primary goal of this study was to determine a dose of RAL that was safe and met the PK targets for infants when administered during the first 6 weeks of life in addition to standard of care antiretroviral (ARV) agents for prevention of perinatal transmission.
Primary Outcome
Number of infants who died or had adverse events (AEs) of Grade 3 or 4 as defined in DAIDS AE Grading Table. Events with onset dates prior to first RAL dosing and congenital anomalies assessed as baseline by the study team were considered baseline events and not AEs.
Conditions Studied
Interventions
- DRUG Raltegravir
Study Locations (15)
Other
- Hospital Federal dos Servidores do Estado NICHD CRS - Rio de Janeiro
- Hosp. Geral De Nova Igaucu Brazil NICHD CRS - Rio de Janeiro
- Univ. of Sao Paulo Brazil NICHD CRS - São Paulo
- Fam-Cru Crs - Cape Town
Illinois
- Rush Univ. Cook County Hosp. Chicago NICHD CRS - Chicago
- Lurie Children's Hospital of Chicago (LCH) CRS - Chicago
California
- Usc La Nichd Crs - Los Angeles
District of Columbia
- Children's National Med. Ctr. Washington DC NICHD CRS - Washington D.C.
Florida
- Univ. of Florida Jacksonville NICHD CRS - Jacksonville
Massachusetts
- Boston Medical Center Ped. HIV Program NICHD CRS - Boston
New York
- Bronx-Lebanon Hospital Center NICHD CRS - The Bronx
Tennessee
- St. Jude Children's Research Hospital CRS - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2014-01-28 |
| Est. Completion | 2018-04-20 |
| Phase | Phase 1 |
What the finished NCT01780831 record still lists
NCT01780831 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (88% lower).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 1 intervention - of which Raltegravir is the first listed.
NCT01780831 lists 15 locations in 11 states (Other, Illinois, California).
Frequently Asked Questions
What is clinical trial NCT01780831 about?
NCT01780831 is a clinical study titled "Safety and Pharmacokinetics of Raltegravir in HIV-1-Exposed Newborn Infants at Risk of Acquiring HIV-1 Infection". The purpose of this study was to evaluate the safety and pharmacokinetics (PK) of raltegravir (RAL) when given to HIV-1-exposed, normal birth weight newborn infants at risk of acquiring HIV-1 infection. (PK is the study of the time course of absorption, distribution, metabolism, and excretion of dru...
What is the current status of trial NCT01780831?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2014-01-28. Estimated completion is 2018-04-20.
What conditions does trial NCT01780831 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT01780831?
The interventions under investigation include: Raltegravir (DRUG).
Who is sponsoring clinical trial NCT01780831?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01780831 being conducted?
This trial has 15 study locations across California, District of Columbia, Florida, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01780831's enrollment target sits among peer trials
52 351st of 542 higher than 190 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections 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.
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