Standard zidovudine plus infant nevirapine to prevent perinatal HIV in Thailand

Country/Countries:
,

Principal Investigator:
Marc Lallemant, Research Associate in Immunology and Infectious Diseases

Department:
Immunology+Infectious Diseases Thailand

Sponsors:
NIH/NICHD

Dates of Research:
September 29, 2006 — July 31, 2012

Description:

The 2nd Perinatal HIV Prevention Trial (PHPT-2) in Thailand showed that a single dose of nevirapine (SD-NVP) to women at onset of labor and to infants at 48-72 hours in addition to zidovudine (ZDV) starting at 28 weeks’ gestation, could reduce HIV perinatal transmission to ~2%. However, post-exposure NVP resistance mutations detected in mothers have raised concerns regarding future efficacy of Non Nucleoside Reverse Transcriptase Inhibitor based treatments for their own health. The primary objective of this study is to test whether maternal SD-NVP can be omitted without loss of efficacy in preventing perinatal HIV transmission. A regime with no maternal NVP and two infant NVP doses, one immediately after birth, the other after 48-72 hours, will be compared for efficacy with a regimen including a maternal NVP does during labor and identical infant NVP dosing. The secondary objectives of the project are to study HIV resistance mutations to NVP in HIV infected infants, to compare the safety of both strategies in mothers and infants, and to study the pharmacokinetics of NVP in infants.

Website: http://clinicaltrials.gov/archive/NCT00409591/2007_01_10