Evaluating the Safety and Pharmacokinetics of Raltegravir in Infants
Completed
Conditions studied: HIV Infections
In brief
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).
Key facts
- Study ID
- NCT01828073
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 40
- Starts
- 2011-05-19
- Expected to finish
- 2018-04-23
- Last updated by the study team
- 2021-11-08
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of California, UC San Diego CRS- Mother-Child-Adolescent HIV Program — La Jolla, California, United States
- Miller Children's Hosp. Long Beach CA NICHD CRS — Long Beach, California, United States
- Usc La 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 Florida Jacksonville NICHD CRS — Jacksonville, Florida, United States
- Johns Hopkins Univ. Baltimore NICHD CRS — Baltimore, Maryland, 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
- Jacobi Med. Ctr. Bronx NICHD CRS — The Bronx, New York, United States
- St. Jude Children's Research Hospital CRS — Memphis, Tennessee, United States
- Seattle Children's Research Institute CRS — Seattle, Washington, United States
- Hospital Nossa Senhora da Conceicao NICHD CRS — Porto Alegre, Rio Grande do Sul, Brazil
- 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
- Soweto IMPAACT CRS — Johannesburg, Gauteng, South Africa
- Kilimanjaro Christian Medical Centre (KCMC) — Moshi, Tanzania
- Chiangrai Prachanukroh Hospital NICHD CRS — Chiang Mai, Thailand
Full record on ClinicalTrials.gov
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