Safety and Pharmacokinetics of Raltegravir in HIV-1-Exposed Newborn Infants at Risk of Acquiring HIV-1 Infection

PHASE1CompletedINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

January 28, 2014

Primary Completion Date

December 14, 2017

Study Completion Date

April 20, 2018

Conditions
HIV Infections
Interventions
DRUG

Raltegravir

RAL was given as oral granules for suspension.

Trial Locations (15)

4001

Umlazi CRS, Durban

7505

Fam-Cru Crs, Cape Town

10457

Bronx-Lebanon Hospital Center NICHD CRS, The Bronx

10700

Siriraj Hospital ,Mahidol University NICHD CRS, Bangkok

20010

Children's National Med. Ctr. Washington DC NICHD CRS, Washington D.C.

26030

Hosp. Geral De Nova Igaucu Brazil NICHD CRS, Rio de Janeiro

32209

Univ. of Florida Jacksonville NICHD CRS, Jacksonville

60612

Rush Univ. Cook County Hosp. Chicago NICHD CRS, Chicago

90089

Usc La Nichd Crs, Los Angeles

60614-3393

Lurie Children's Hospital of Chicago (LCH) CRS, Chicago

02118

Boston Medical Center Ped. HIV Program NICHD CRS, Boston

38105-3678

St. Jude Children's Research Hospital CRS, Memphis

20221-903

Hospital Federal dos Servidores do Estado NICHD CRS, Rio de Janeiro

14049-900

Univ. of Sao Paulo Brazil NICHD CRS, São Paulo

00935

University of Puerto Rico Pediatric HIV/AIDS Research Program CRS, San Juan

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT01780831 - Safety and Pharmacokinetics of Raltegravir in HIV-1-Exposed Newborn Infants at Risk of Acquiring HIV-1 Infection | Biotech Hunter | Biotech Hunter