Kaposi SarcomaPhase 3NCT05411237
Paclitaxel and Pegylated Liposomal Doxorubicin for Treatment of HIV-related Kaposi Sarcoma
A Phase 3 study testing Pegylated liposomal doxorubicin and Paclitaxel in people with Kaposi Sarcoma and HIV-1-infection, run by AIDS Malignancy Consortium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kaposi Sarcoma, HIV-1-infection, AIDS-related Kaposi Sarcoma
- What is being tested?
- Pegylated liposomal doxorubicin and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Sep 2030
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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).
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- 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.
- 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.
- 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.
- 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.
- 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.
- Adequate venous access.
- No prior chemotherapy or use of systemic cytotoxic therapy agents.
- Participant is able to understand and willing to sign a written informed consent document.
Who cannot join
- 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
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- 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
- 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.
- Corticosteroid use at doses above those given for replacement therapy for adrenal insufficiency within the last 30 days prior to study entry.
- Patients with psychiatric illness and/or social circumstances that would limit compliance with study requirements.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
- Conditions
- Kaposi Sarcoma, HIV-1-infection, AIDS-related Kaposi Sarcoma
- Being tested
- Pegylated liposomal doxorubicin, Paclitaxel
- Keywords
- Paclitaxel, Pegylated liposomal doxorubicin, AIDS associated Kaposi Sarcoma, Human Immunodeficiency Virus, HIV-related Kaposi Sarcoma
- Medical subject headings
- Sarcoma, Kaposi, AIDS-related Kaposi sarcoma, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated liposomal doxorubicinDrug
Also called Doxil
PLD 20 mg/m2 on Day 1 of every 21-day cycle
PaclitaxelDrug
Also called Taxol
PTX 100 mg/m2 on Day 1 of every 21-day cycle
| Study group | Role | What they receive |
|---|---|---|
| Pegylated Liposomal Doxorubicin | Active comparator | Participants will receive a single intravenous dose of PLD 20 mg/m2 once every 3 weeks for a total of 18 weeks. Receives: Drug: Pegylated liposomal doxorubicin |
| Paclitaxel | Active comparator | Participants will receive a single intravenous dose of PTX 100 mg/m2 once every 3 weeks for a total of 18 weeks. Receives: Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival at 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
Measured: 48 weeks
Secondary outcomes (3)
Frequency and severity of adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 in participants receiving PLD or PTX.
The frequency of adverse events that occur in patients receiving PLD will be compared with the frequency of adverse events in patients receiving PTX
Measured: 96 weeks
Objective response rate for AIDS-related KS in patients receiving PLD and PTX
The objective response rate is defined as the sum of the number of complete and partial responses in patients receiving PLD or PTX.
Measured: 96 weeks
Duration of Response in patients receiving PLD and PTX
Response duration is defined as the time from first documentation of complete or partial response as measured by KS response criteria to the documentation of first progression of disease as measured by KS response criteria
Measured: 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study startSep 2026 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kaposi SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AIDS Malignancy Consortium
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Susan Krown, MD, Study chair, AIDS Malignancy Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05411237
- Sponsor's protocol ID
- AMC-114
- Other IDs
- U01CA121947
- Status last verified
- Jan 2026
- First submitted
- 6 Jun 2022
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chapola JC, Kleber SL, Krown SE, Painschab M. Cost-effectiveness protocol for treating adult HIV-infected patients with Kaposi sarcoma in resource-limited settings: a phase III, randomized, open-label, non-inferiority study of paclitaxel and pegylated liposomal doxorubicin. Cost Eff Resour Alloc. 2025 Nov 24;23(1):78. doi: 10.1186/s12962-025-00677-x.
PubMed 41286911