{"entity":{"id":"actg-a5263","kind":"trial","name":"ACTG A5263/AMC 066","aka":["ACTG A5263","A5263","AMC 066"],"tldr":"ACTG A5263 tested whether two cheaper, easier chemotherapies could replace paclitaxel for people with HIV and advanced Kaposi sarcoma in Africa; both were clearly worse, so paclitaxel with antiretroviral therapy is the treatment to aim for wherever it can be supplied.","summary":"ACTG A5263/AMC 066 was a three-arm open-label randomised non-inferiority trial at sites in Kenya, Malawi, South Africa, Uganda, Zimbabwe and Brazil in 334 adults with advanced AIDS-associated Kaposi sarcoma starting antiretroviral therapy (efavirenz, emtricitabine and tenofovir). Patients were randomised to paclitaxel, oral etoposide, or bleomycin with vincristine. The primary endpoint was progression-free survival at week 48.\n\nThe etoposide arm was closed for inferiority in 2016 and the bleomycin-vincristine arm in 2018, ending the trial early. Week-48 progression-free survival was 50 percent with paclitaxel against 20 percent with etoposide, and 64 percent with paclitaxel against 44 percent with bleomycin-vincristine; the confidence intervals excluded non-inferiority for both. Adverse events were similar across arms. The corpus's Kaposi sarcoma page cites the trial for antiretroviral therapy plus paclitaxel where available, with bleomycin-vincristine otherwise.","status":"positive","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01435018","url":"https://clinicaltrials.gov/study/NCT01435018"}],"tags":["soc-trials"],"related":[],"cancers":["kaposi-sarcoma","vascular-tumours","sarcoma"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["paclitaxel","etoposide","bleomycin","vincristine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-actg-a5263-kaposi-sarcoma-resource-limited-krown-lancet-2020"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01435018","phase":"3","setting":"Advanced AIDS-associated Kaposi sarcoma in resource-limited settings in Africa and South America: antiretroviral therapy with paclitaxel (standard), oral etoposide or bleomycin plus vincristine, with progression-free survival at 48 weeks as the primary endpoint of a non-inferiority design","sponsor":"AIDS Clinical Trials Group (Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections)","result":"Week-48 progression-free survival 50 percent with paclitaxel against 20 percent with oral etoposide, and 64 percent against 44 percent with bleomycin plus vincristine; both investigational arms were inferior and closed early.","yearReported":2020,"enrolled":334,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival at week 48, paclitaxel against etoposide (non-inferiority)","primary":true,"unit":"%","arms":[{"name":"Paclitaxel + antiretroviral therapy","n":59,"value":50,"note":"95% CI 32 to 67"},{"name":"Oral etoposide + antiretroviral therapy","n":59,"value":20,"note":"95% CI 6 to 33; arm closed for inferiority in March 2016"}],"source":"https://doi.org/10.1016/S0140-6736(19)33222-2"},{"endpoint":"Progression-free survival at week 48, paclitaxel against bleomycin plus vincristine (non-inferiority)","primary":true,"unit":"%","arms":[{"name":"Paclitaxel + antiretroviral therapy","n":138,"value":64,"note":"95% CI 55 to 73"},{"name":"Bleomycin + vincristine + antiretroviral therapy","n":132,"value":44,"note":"95% CI 35 to 53; arm closed for inferiority in March 2018"}],"source":"https://doi.org/10.1016/S0140-6736(19)33222-2"},{"endpoint":"Absolute difference in week-48 progression-free survival, etoposide minus paclitaxel","unit":"percentage points","arms":[{"name":"Oral etoposide against paclitaxel","value":-30,"note":"95% CI -52 to -8"}],"source":"https://doi.org/10.1016/S0140-6736(19)33222-2"},{"endpoint":"Absolute difference in week-48 progression-free survival, bleomycin-vincristine minus paclitaxel","unit":"percentage points","arms":[{"name":"Bleomycin + vincristine against paclitaxel","value":-20,"note":"95% CI -33 to -7"}],"source":"https://doi.org/10.1016/S0140-6736(19)33222-2"}]},"route":"/trials/actg-a5263/","neighbours":{"cancer":[{"id":"kaposi-sarcoma","kind":"cancer","name":"Kaposi sarcoma","route":"/cancers/kaposi-sarcoma/"},{"id":"sarcoma","kind":"cancer","name":"Sarcomas (soft tissue, bone, GIST)","route":"/cancers/sarcoma/"},{"id":"vascular-tumours","kind":"cancer","name":"Vascular tumours (angiosarcoma, epithelioid haemangioendothelioma, kaposiform haemangioendothelioma)","route":"/cancers/vascular-tumours/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"}],"drug":[{"id":"bleomycin","kind":"drug","name":"Bleomycin","route":"/drugs/bleomycin/"},{"id":"etoposide","kind":"drug","name":"Etoposide","route":"/drugs/etoposide/"},{"id":"paclitaxel","kind":"drug","name":"Paclitaxel / nab-paclitaxel","route":"/drugs/paclitaxel/"},{"id":"vincristine","kind":"drug","name":"Vincristine","route":"/drugs/vincristine/"}],"paper":[{"id":"paper-actg-a5263-kaposi-sarcoma-resource-limited-krown-lancet-2020","kind":"paper","name":"ACTG A5263/AMC 066: three chemotherapy regimens with antiretroviral therapy for advanced AIDS-associated Kaposi sarcoma in resource-limited settings","route":"/key-papers/paper-actg-a5263-kaposi-sarcoma-resource-limited-krown-lancet-2020/"}]}}