Three Chemo Regimens as an Adjunct to ART for Treatment of Advanced AIDS-KS

PHASE3CompletedINTERVENTIONAL
Enrollment

334

Participants

Timeline

Start Date

October 1, 2013

Primary Completion Date

March 13, 2018

Study Completion Date

August 29, 2019

Conditions
HIV-1 Infection
Interventions
DRUG

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."

DRUG

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."

DRUG

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.

DRUG

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"

Trial Locations (11)

7505

Family Clinical Research Unit (FAM-CUR) CRS (8950), Cape Town

21045

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

30100

Moi University International Clnical Trials Unit, Eldoret

40100

Kenya Medical Research Institute/Center for Disease Control (KEMRI/CDC) CRS (31460), Kisumu

Unknown

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

4013 SF

Durban Adult HIV CRS (11201), Durban

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

collaborator

National Cancer Institute (NCI)

NIH

collaborator

National Institute of Dental and Craniofacial Research (NIDCR)

NIH

collaborator

AIDS Malignancy Consortium

NETWORK

lead

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

NETWORK

NCT01435018 - Three Chemo Regimens as an Adjunct to ART for Treatment of Advanced AIDS-KS | Biotech Hunter | Biotech Hunter