Safety and Pharmacokinetics of Raltegravir in HIV-1-Exposed Newborn Infants at Risk of Acquiring HIV-1 Infection
Completed · Phase 1
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT01780831
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 52
- Starts
- 2014-01-28
- Expected to finish
- 2018-04-20
- Last updated by the study team
- 2021-11-05
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Usc La Nichd Crs — Los Angeles, California, United States
- Children's National Med. Ctr. Washington DC NICHD CRS — Washington D.C., District of Columbia, United States
- Univ. of Florida Jacksonville NICHD CRS — Jacksonville, Florida, United States
- Rush Univ. Cook County Hosp. Chicago NICHD CRS — Chicago, Illinois, United States
- Lurie Children's Hospital of Chicago (LCH) CRS — Chicago, Illinois, United States
- Boston Medical Center Ped. HIV Program NICHD CRS — Boston, Massachusetts, United States
- Bronx-Lebanon Hospital Center NICHD CRS — The Bronx, New York, United States
- St. Jude Children's Research Hospital CRS — Memphis, Tennessee, United States
- Hospital Federal dos Servidores do Estado NICHD CRS — Rio de Janeiro, Brazil
- Hosp. Geral De Nova Igaucu Brazil NICHD CRS — Rio de Janeiro, Brazil
- Univ. of Sao Paulo Brazil NICHD CRS — São Paulo, Brazil
- University of Puerto Rico Pediatric HIV/AIDS Research Program CRS — San Juan, PR, Puerto Rico
- Umlazi CRS — Durban, KwaZulu-Natal, South Africa
- Fam-Cru Crs — Cape Town, South Africa
- Siriraj Hospital ,Mahidol University NICHD CRS — Bangkok, Bangkoknoi, Thailand
Full record on ClinicalTrials.gov
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