Antiretroviral Therapy (ART) Alone or With Delayed Chemo Versus ART With Immediate Chemo for Limited AIDS-related Kaposi's Sarcoma

PHASE3CompletedINTERVENTIONAL
Enrollment

192

Participants

Timeline

Start Date

November 18, 2011

Primary Completion Date

March 16, 2016

Study Completion Date

November 29, 2018

Conditions
HIV-1 InfectionKaposi's Sarcoma
Interventions
DRUG

efavirenz/emtricitabine/tenofovir disoproxil fumarate

600 mg efavirenz/200 mg emtricitabine/300 mg tenofovir disoproxil fumarate taken orally at night

DRUG

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.

Trial Locations (8)

20200

Walter Reed Project - Kenya Med. Research Institute Kericho CRS (12501), Kericho

21045

Instituto de Pesquisa Clinica Evandro Chagas (12101), Rio de Janeiro

Unknown

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

4013 SF

Durban Adult HIV CRS (11201), Durban

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

lead

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

NETWORK

NCT01352117 - Antiretroviral Therapy (ART) Alone or With Delayed Chemo Versus ART With Immediate Chemo for Limited AIDS-related Kaposi's Sarcoma | Biotech Hunter | Biotech Hunter