Paclitaxel and Pegylated Liposomal Doxorubicin for Treatment of HIV-related Kaposi Sarcoma (NCT05411237) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Paclitaxel and Pegylated Liposomal Doxorubicin for Treatment of HIV-related Kaposi Sarcoma
130 participantsStarted 2026-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. HIV-1 infection.
. Histologically confirmed KS at any time prior to study entry, confirmed by an AIDS Malignancy Consortium (AMC)-certified pathologist.
. Current stage T1 KS (irrespective of prior treatment with antiretroviral therapy (ART) OR
. Men and women ≥ 18 years. Because no dosing or adverse event data are currently available on the use of PTX or PLD for AIDS-KS in persons \<18 years of age, children are excluded from this study
. Karnofsky performance status ≥ 60 (ECOG ≤ 2).
. Echocardiogram or Multiple gated acquisition scanning (MUGA) showing an ejection fraction ≥ 50%.
. Ability and willingness of participant or legal guardian to provide informed consent.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Participants may be ART-naïve or ART-experienced but must be able to receive an ART regimen considered likely to result in HIV suppression.
Exclusion criteria
. Current acute, chronic, or recurrent infections that are serious, in the opinion of the site investigator, for which the participant has not completed at least 14 days of therapy before study entry and/or is not clinically stable.
. Serious illness necessitating hospitalization/systemic treatment within 14 days prior to study entry
. Breastfeeding or pregnant women are excluded because of potential risks of cytotoxic chemotherapy to an unborn child or infant.
. Known history of congestive heart failure and/or systolic ejection fraction \< 50%.
. Prior radiotherapy to KS indicator lesions
. Prior or current immunotherapy
. Any immunomodulator, HIV vaccine, live attenuated vaccine, other investigational vaccine within 30 days prior to study entry, excluding vaccines against COVID-19/SARS-CoV-2, which are permitted.
. Known allergy/hypersensitivity to the study drug or its formulation