192
Participants
Start Date
November 18, 2011
Primary Completion Date
March 16, 2016
Study Completion Date
November 29, 2018
efavirenz/emtricitabine/tenofovir disoproxil fumarate
600 mg efavirenz/200 mg emtricitabine/300 mg tenofovir disoproxil fumarate taken orally at night
etoposide
50 mg taken orally daily from days 1-7 of each 2-week cycle. For participants without PR or CR after two cycles of therapy and no toxicity greater than Grade 2, the dose of ET was escalated to 100 mg/day orally, days 1-7, every 2 weeks. A cycle could be delayed for a maximum of 14 days. ET could not be initiated prior to 7 days after the last dose in previous cycle. ET could be administered up to a maximum of eight cycles (2 cycles during dose titration and 6 cycles at maximum dose). Participants who could not tolerate escalation of the ET dose to 100 mg/day were treated for a maximum of six cycles.
Walter Reed Project - Kenya Med. Research Institute Kericho CRS (12501), Kericho
Instituto de Pesquisa Clinica Evandro Chagas (12101), Rio de Janeiro
College of Med. JHU CRS (30301), Blantyre
University of North Carolina Lilongwe CRS (12001), Lilongwe
San Miguel CRS, San Miguel
Wits HIV CRS, Johannesburg
JCRC CRS, Kampala
Durban Adult HIV CRS (11201), Durban
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
NETWORK