# ACTG A5263/AMC 066

Source: https://onco.cc/trials/actg-a5263/  
OnCo record `actg-a5263` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

The 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.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-22
- Also known as: ACTG A5263; A5263; AMC 066
- Tags: soc-trials
- Registry id: 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)
- Enrolled: 334
- 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.
- Outcomes: Progression-free survival at week 48, paclitaxel against etoposide (non-inferiority): Paclitaxel + antiretroviral therapy 50% vs Oral etoposide + antiretroviral therapy 20%; Progression-free survival at week 48, paclitaxel against bleomycin plus vincristine (non-inferiority): Paclitaxel + antiretroviral therapy 64% vs Bleomycin + vincristine + antiretroviral therapy 44%; Absolute difference in week-48 progression-free survival, etoposide minus paclitaxel: Oral etoposide against paclitaxel -30 percentage points; Absolute difference in week-48 progression-free survival, bleomycin-vincristine minus paclitaxel: Bleomycin + vincristine against paclitaxel -20 percentage points

## Sources

- ClinicalTrials.gov NCT01435018: https://clinicaltrials.gov/study/NCT01435018

## Connected records

- cancers: [Kaposi sarcoma](https://onco.cc/cancers/kaposi-sarcoma/), [Sarcomas (soft tissue, bone, GIST)](https://onco.cc/cancers/sarcoma/), [Vascular tumours (angiosarcoma, epithelioid haemangioendothelioma, kaposiform haemangioendothelioma)](https://onco.cc/cancers/vascular-tumours/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/)
- drugs: [Bleomycin](https://onco.cc/drugs/bleomycin/), [Etoposide](https://onco.cc/drugs/etoposide/), [Paclitaxel / nab-paclitaxel](https://onco.cc/drugs/paclitaxel/), [Vincristine](https://onco.cc/drugs/vincristine/)
- key papers: [ACTG A5263/AMC 066: three chemotherapy regimens with antiretroviral therapy for advanced AIDS-associated Kaposi sarcoma in resource-limited settings](https://onco.cc/key-papers/paper-actg-a5263-kaposi-sarcoma-resource-limited-krown-lancet-2020/)

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