334
Participants
Start Date
October 1, 2013
Primary Completion Date
March 13, 2018
Study Completion Date
August 29, 2019
Etoposide (ET)
"Beginning on day one of the chemotherapy cycle, ET was given orally in a dose of 50 mg twice daily for 7 consecutive days for the first cycle. If there was no Grade \>= 2 toxicity attributable to ET after the first cycle, the dose was escalated to 150 mg daily for 7 days in divided doses of 100 mg/50 mg for the second cycle. After the second cycle, if there was no Grade \>= 2 toxicity attributable to ET, the dose was escalated to 100 mg twice daily for 7 days for the third and subsequent cycles.~Treatment with ET was continued for six cycles at the maximum dose achieved or until toxicity requiring discontinuation of study chemotherapy, or the site investigator, after consulting with the protocol CMC, had determined that alternative therapy is required, whichever occurs first."
Bleomycin and Vincristine (BV)
"BV was administered on day one of each chemotherapy cycle.~Vincristine sulfate was administered at a dose of 2 mg (fixed dose) in a volume of 2 mL over 1 minute into the sidearm of a rapidly flowing intravenous infusion every 3 weeks. The vincristine infusion was followed by bleomycin as detailed below.~Bleomycin sulfate was administered at a dose of 15 units/m\^2 over 10 minutes every 3 weeks.~Treatment with BV was continued for six cycles, or until toxicity requiring discontinuation of study chemotherapy, or the site investigator, after consulting with the protocol CMC, had determined that alternative therapy is required, whichever occurs first."
Paclitaxel (PTX)
Paclitaxel was administered by IV infusion in 200 mL, 250 mL, or 500 mL of 5% dextrose or 0.9%Sodium Chloride for injection at a dose of 100 mg/m\^2 body surface area (BSA) every 3 weeks.
Co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF)
"The following ART regimens were used:~1. EFV/FTC/TDF (Atripla) 200 mg/300 mg/600 mg orally once daily at bedtime or~2. FTC/TDF 200 mg/300 mg (Truvada) orally once daily at bedtime plus EFV (Stocrin) 600 mg orally once daily at bedtime or~3. FTC/TDF 200 mg/300 mg (Truvada) orally once daily plus nevirapine (NVP) 200 mg orally twice daily or~4. FTC/TDF 200 mg/300 mg (Truvada) orally once daily plus PI/r at standard dosing or~5. FTC/TDF 200 mg/300 mg (Truvada) orally once daily plus integrase inhibitor at standard dosing"
Family Clinical Research Unit (FAM-CUR) CRS (8950), Cape Town
Instituto de Pesquisa Clinica Evandro Chagas (12101), Rio de Janeiro
Moi University International Clnical Trials Unit, Eldoret
Kenya Medical Research Institute/Center for Disease Control (KEMRI/CDC) CRS (31460), Kisumu
KMRI / Walter Reed Project Clinical Research Center, Kericho
Univ. of Malawi, John Hopkins Project, Blantyre
Malawi CRS (12001), Lilongwe
University of Witwatersrand, Johannesburg
Uganda Cancer Institute ACTG CRS, Kampala
UZ-Parirenyatwa CRS (30313), Harare
Durban Adult HIV CRS (11201), Durban
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
National Cancer Institute (NCI)
NIH
National Institute of Dental and Craniofacial Research (NIDCR)
NIH
AIDS Malignancy Consortium
NETWORK
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
NETWORK