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 range18 Years
SexALL
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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.
✓. 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