Safety and Pharmacokinetics of Raltegravir in HIV-1-Exposed Newborn Infants at Risk of Acquiring HIV-1 Infection
Status:
Completed
Trial end date:
2018-04-20
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)