Safety and Pharmacokinetics (PK) of Raltegravir in HIV (Human Immunodeficiency Virus)-Infected Children and Adolescents
Completed · Phase 1/Phase 2
Conditions studied: HIV Infections
In brief
Integrase is 1 of 3 HIV (Human Immunodeficiency Virus)-1 enzymes required for viral replication. Raltegravir is a drug that prevents integrase from working properly. This drug has been tested for safety and efficacy in adults, but this is the first study to examine raltegravir in children and adolescents. The purpose of this study was to determine the appropriate dose for raltegravir across the pediatric age range from 4 weeks to 18 years of age, by acquiring short and long term safety data, intensive and population pharmacokinetic (PK) data, and efficacy experience with raltegravir in HIV-infected children and adolescents.
Key facts
- Study ID
- NCT00485264
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 153
- Starts
- 2007-09-17
- Expected to finish
- 2017-05-18
- Last updated by the study team
- 2021-11-02
Who can join
Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Usc La Nichd Crs — Alhambra, California, United States
- University of California, UC San Diego CRS — La Jolla, California, United States
- Children's Hospital of Los Angeles NICHD CRS — Los Angeles, California, United States
- David Geffen School of Medicine at UCLA NICHD CRS — Los Angeles, California, United States
- Univ. of California San Francisco NICHD CRS — San Francisco, California, United States
- Univ. of Colorado Denver NICHD CRS — Aurora, Colorado, United States
- Children's National Med. Ctr. Washington DC NICHD CRS — Washington D.C., District of Columbia, United States
- Howard Univ. Washington DC NICHD CRS — Washington D.C., District of Columbia, United States
- South Florida CDTC Ft Lauderdale NICHD CRS — Fort Lauderdale, Florida, United States
- Univ. of Florida Jacksonville NICHD CRS — Jacksonville, Florida, United States
- USF - Tampa NICHD CRS — Tampa, Florida, United States
- Rush Univ. Cook County Hosp. Chicago NICHD CRS — Chicago, Illinois, United States
- Ann & Robert H. Lurie Children's Hospital of Chicago (LCH) CRS — Chicago, Illinois, United States
- Tulane Univ. New Orleans NICHD CRS — New Orleans, Louisiana, United States
- Johns Hopkins Univ. Baltimore NICHD CRS — Baltimore, Maryland, United States
- Children's Hosp. of Boston NICHD CRS — Boston, Massachusetts, United States
- Boston Medical Center Ped. HIV Program NICHD CRS — Boston, Massachusetts, United States
- WNE Maternal Pediatric Adolescent AIDS CRS — Worcester, Massachusetts, United States
- Nyu Ny Nichd Crs — New York, New York, United States
- Metropolitan Hosp. NICHD CRS — New York, New York, United States
- Columbia IMPAACT CRS — New York, New York, United States
- SUNY Stony Brook NICHD CRS — Stony Brook, New York, United States
- Bronx-Lebanon Hospital Center NICHD CRS — The Bronx, New York, United States
- Jacobi Med. Ctr. Bronx NICHD CRS — The Bronx, New York, United States
- DUMC Ped. CRS — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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