drugset / Trial / NCT01435018
Three Chemo Regimens as an Adjunct to ART for Treatment of Advanced AIDS-KS
Phase 3
Completed
334 enrolled
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
AIDS Malignancy Consortium · collabNational Cancer Institute (NCI) · collabNational Institute of Allergy and Infectious Diseases (NIAID) · collabNational Institute of Dental and Craniofacial Research (NIDCR) · collab
RandomizedParallel-groupOpen-labelTreatment
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).
Timeline
- Start
- 2013-10-01
- Primary completion
- 2018-03-13
- Completion
- 2019-08-29
Publications
- Background Krown SE, Metroka C, Wernz JC. Kaposi's sarcoma in the acquired immune deficiency syndrome: a proposal for uniform evaluation, response, and staging criteria. AIDS Clinical Trials Group Oncology Committee. J Clin Oncol. 1989 Sep;7(9):1201-7. doi: 10.1200/JCO.1989.7.9.1201.
- Background Cianfrocca M, Cooley TP, Lee JY, Rudek MA, Scadden DT, Ratner L, Pluda JM, Figg WD, Krown SE, Dezube BJ. Matrix metalloproteinase inhibitor COL-3 in the treatment of AIDS-related Kaposi's sarcoma: a phase I AIDS malignancy consortium study. J Clin Oncol. 2002 Jan 1;20(1):153-9. doi: 10.1200/JCO.2002.20.1.153.
- Results Krown SE, Moser CB, MacPhail P, Matining RM, Godfrey C, Caruso SR, Hosseinipour MC, Samaneka W, Nyirenda M, Busakhala NW, Okuku FM, Kosgei J, Hoagland B, Mwelase N, Oliver VO, Burger H, Mngqibisa R, Nokta M, Campbell TB, Borok MZ; A5263/AMC066 protocol team. Treatment of advanced AIDS-associated Kaposi sarcoma in resource-limited settings: a three-arm, open-label, randomised, non-inferiority trial. Lancet. 2020 Apr 11;395(10231):1195-1207. doi: 10.1016/S0140-6736(19)33222-2. Epub 2020 Mar 5.
- Epeldegui M, Moser C, Choi Y, Borok M, Campbell TB, MacPhail P, Hosseinipour MC, Samaneka W, Nyirenda M, Kosgei J, Busakhala N, Martinez-Maza O, Krown SE; AMC-066/A5263 study team. Serum Biomarkers in Advanced-Stage AIDS-Associated Kaposi Sarcoma in Resource Limited Settings. J Acquir Immune Defic Syndr. 2026 Apr 1;101(4):416-423. doi: 10.1097/QAI.0000000000003805.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bleomycin | Unknown | 15 iu | Intravenous |
| Subject | Etoposide | Small molecule | 100 mg | Oral |
| Comparator | Paclitaxel | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Vincristine | Small molecule | 2 mg | Intravenous |
| Background | Efavirenz | Other / unclassified | 200 mg | Oral |
| Background | Efavirenz | Other / unclassified | 600 mg | Oral |
| Background | Nevirapine | Small molecule | 200 mg | Oral |
| Background | Tenofovir disoproxil fumarate | Small molecule | 300 mg | Oral |
| Background | Tenofovir disoproxil fumarate | Small molecule | 600 mg | Oral |
| Background | emtricitabine | Other / unclassified | 200 mg | Oral |
| Background | emtricitabine | Other / unclassified | 300 mg | Oral |