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

NCT05411237 Phase 3 NOT_YET_RECRUITING

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.

Details

Lead sponsor	AIDS Malignancy Consortium
Phase	Phase 3
Status	NOT_YET_RECRUITING
Enrolment	130
Start date	2026-09
Completion	2030-09

Conditions

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

Interventions

• Pegylated liposomal doxorubicin
• Paclitaxel

Primary outcomes

• Progression Free Survival at 48 weeks — 48 weeks
  Progression free survival (PFS) is defined as the length of time from enrollment into the study until disease progression or death. Disease progression will be assessed using the Kaposi Sarcoma Response Evaluation Criteria. Progressive disease is defined as: 1) 25% increase in the sum of perpendicular diameters of the indicator lesions; 2) 25% increase in the total number of KS lesions or the appearance of 5 new lesions; OR 3) 25% increase in the number of raised lesions