NCT05411237

Paclitaxel and Pegylated Liposomal Doxorubicin for Treatment of HIV-related Kaposi Sarcoma

A Phase III, Randomized, Open-Label, Non-Inferiority Study of Paclitaxel and Pegylated Liposomal Doxorubicin for Treatment of HIV-related Kaposi Sarcoma in Resource-Limited Settings

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: AIDS Malignancy Consortium · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being done to determine if two different anti-cancer drugs, paclitaxel (PTX) and pegylated liposomal doxorubicin (PLD) have similar effects on treating Kaposi Sarcoma (KS) in people living with HIV (human immunodeficiency virus) in sub-Saharan Africa. Patients with HIV-related KS will receive either PTX or PLD once every 3 weeks for a total of six cycles.

Conditions

• Kaposi Sarcoma
• HIV-1-infection
• AIDS-related Kaposi Sarcoma

Interventions

Type	Name	Description
DRUG	Pegylated liposomal doxorubicin	PLD 20 mg/m2 on Day 1 of every 21-day cycle
DRUG	Paclitaxel	PTX 100 mg/m2 on Day 1 of every 21-day cycle

Timeline

• Start date: 2026-09-01
• Primary completion: 2029-09-01
• Completion: 2030-09-01
• First posted: 2022-06-09
• Last updated: 2026-01-23