Phase II, Parallel, Randomized, Clinical Trials Comparing The Responses To Initiation of NNRTI-based Versus PI-Based Antiretroviral Therapy in HIV-Infected Infants Who Have And Have Not Previously Received Single Dose Nevirapine For Prevention of Mother-To-Child HIV Transmission (Version 5.0)
Sponsors: US National Institute of Allergy and Infectious Diseases (NIAID)
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Protocol Summary: P1060 Version 5.0 is an observational study providing valuable comparative information on the long term outcomes of infants and young children initiated on an NNRTI-based (NVP) versus a PI-based (LPV/r) treatment at an early age. The primary objectives of the observational study are to assess the relative long term safety, efficacy, changes in CD4 cell count and growth in children starting ARV treatment on NVP–based versus LPV/r-based HAART regimens.
Years: 2011 – 2016
Investigator: Mutsawashe Bwakura-Dangarembizi, MBChB, MMED, MSc Cli.Epi
Location: Parirenyatwa CRS