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

Sponsor
AIDS Malignancy Consortium
Study ID
NCT05411237
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Jun 9, 2022
Start date
Sep 30, 2026
Status verified
Jan 2026
Primary completion
Sep 30, 2029
Completion
Sep 30, 2030

Study Design

Enrollment
130 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Pegylated Liposomal Doxorubicin
    Participants will receive a single intravenous dose of PLD 20 mg/m2 once every 3 weeks for a total of 18 weeks.
  • Active Comparator: Paclitaxel
    Participants will receive a single intravenous dose of PTX 100 mg/m2 once every 3 weeks for a total of 18 weeks.

Primary Outcome Measure

Progression Free Survival at 48 weeks [ Time Frame: 48 weeks ]

Central Contacts

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