24
Participants
Start Date
April 30, 2016
Primary Completion Date
March 15, 2021
Study Completion Date
March 15, 2021
VRC01
40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump
Placebo for VRC01
Administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump
Antiretroviral therapy (ART) (regimen will vary within countries and by patient)
ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.
SEARCH Thai Red Cross AIDS Research Centre Non-Network CRS, Bangkok
Kenya Med. Research Inst./Walter Reed Project, Clinical Research Centre, Off Hospital Road. Kericho, Kericho
National Institute for Medical Research (NIMR)-Mbeya Medical Research Center (MMRC) Non-Network CRS, Mbeya
ECHO Center Non-Network CRS, Chon Buri
Makerere University Walter Reed Project (MUWRP), Kampala
National Institute of Allergy and Infectious Diseases (NIAID)
NIH