New hope for HIV patients: cheaper chemo may work just as well for kaposi sarcoma
NCT ID NCT05411237
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether two different chemotherapy drugs, paclitaxel and pegylated liposomal doxorubicin, work equally well for treating Kaposi sarcoma in people living with HIV in sub-Saharan Africa. About 130 participants will receive one of the drugs every three weeks for six cycles. The main goal is to see how long the cancer stays under control and to compare side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 130 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2030
An estimate. End dates often move.
- Lead sponsor
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A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. HIV-1 infection. 2. Histologically confirmed KS at any time prior to study entry, confirmed by an AIDS Malignancy Consortium (AMC)-certified pathologist. 3. Current stage T1 KS (irrespective of prior treatment with antiretroviral therapy (ART) OR Stage T0 KS that has progressed or not responded after a minimum of 12 weeks of treatment with ART. Participants with T0 KS must have either: * 20 or more skin and/or oral KS lesions, and/or * any number of lesions on exposed body areas that have an adverse effect on quality of life (e.g., stigmatization). 4. 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 5. Karnofsky performance status ≥ 60 (ECOG ≤ 2). 6. Echocardiogram or Multiple gated acquisition scanning (MUGA) showing an ejection fraction ≥ 50%. 7. Ability and willingness of participant or legal guardian to provide informed consent. 8. Participants may be ART-naïve or ART-experienced but must be able to receive an ART regimen considered likely to result in HIV suppression. 9. Measurable cutaneous KS, defined as follows: * When available, a minimum of five bi-dimensionally measurable KS cutaneous marker lesions. * If fewer than five bi-dimensionally measurable marker lesions are available, the total surface area of the marker lesion(s) must be ≥ 700mm2. 10. The following laboratory values obtained within 14 days prior to study entry: * Absolute Neutrophil Count ≥ 1000 cells/mm3. * Hemoglobin ≥ 8 g/dL (may be achieved with transfusion if clinically indicated, in the opinion of the investigator). * Platelet count ≥ 75,000/mm3. * ALT, AST, Alkaline phosphatase \< 5 × upper limit of normal (ULN). * Total bilirubin: ≤ 1.5 × ULN, unless the participant is receiving an antiretroviral drug known to be associated with increased bilirubin, in which case the direct fraction should be ≤ 2 x the ULN. * Creatinine \< institutional ULN OR estimated glomerular filtration rate (GFR) ≥ 30 mL/min/1.73 m2 for participants with creatinine levels above institutional normal. 11. Women of reproductive potential, defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time during the preceding 24 consecutive months), must have a negative pregnancy test done within 24 hours of initiating the protocol-specified chemotherapy medication. 12. Participants must agree to use two reliable forms of contraception simultaneously while receiving study protocol-specified medication and for 6 months after stopping the medication. 13. Adequate venous access. 14. No prior chemotherapy or use of systemic cytotoxic therapy agents. 15. Participant is able to understand and willing to sign a written informed consent document. Exclusion Criteria: 1. 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. 2. Serious illness necessitating hospitalization/systemic treatment within 14 days prior to study entry 3. Breastfeeding or pregnant women are excluded because of potential risks of cytotoxic chemotherapy to an unborn child or infant. 4. Known history of congestive heart failure and/or systolic ejection fraction \< 50%. 5. Prior radiotherapy to KS indicator lesions 6. Prior or current immunotherapy 7. 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. 8. Known allergy/hypersensitivity to the study drug or its formulation 9. Any condition, including the presence of laboratory abnormalities, which in the opinion of the responsible investigator places the subject at unacceptable risk if they were to participate in the study or confounds the ability to interpret data from the study. 10. Corticosteroid use at doses above those given for replacement therapy for adrenal insufficiency within the last 30 days prior to study entry. 11. Patients with psychiatric illness and/or social circumstances that would limit compliance with study requirements.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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