At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Comparison of Three Regimens of Chemotherapy With Compatible Antiretroviral Therapy for Treatment of Advanced AIDS-KS in Resource-Limited Settings
In Brief
A Phase 3 clinical trial evaluating Etoposide (ET), Bleomycin and Vincristine (BV), and 2 other interventions for HIV-1 Infection. Completed, enrolled 334 participants across 11 sites in 6 countries.
Detailed Summary
This study was done to compare the safety and efficacy of three combination treatments for Kaposi's Sarcoma (KS) and AIDS: 1. Etoposide (ET) plus co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) (ET+ART), 2. Bleomycin and Vincristine (BV) plus co-formulated EFV/FTC/TDF (BV+ART), 3. Paclitaxel (PTX) plus co-formulated EFV/FTC/TDF (PTX+ART).
Study Details
Timeline
Interventions
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.
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 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.
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