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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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
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
Are there results?
Not yet: the study is under way

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.

Margaret Borok- Williams, MD contact

+263 (242) 791-631

mborok@mweb.co.zw

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.

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 groups in NCT05411237
Study groupRoleWhat they receive
Pegylated Liposomal DoxorubicinActive comparatorParticipants 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
PaclitaxelActive comparatorParticipants 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.

  1. 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)

  1. 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

  2. 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

  3. 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.

  1. First posted9 Jun 2022
  2. Study startSep 2026 (estimated)
  3. Primary completionSep 2029 (estimated)
  4. Study completionSep 2030 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pegylated liposomal doxorubicin and Paclitaxel in people with Kaposi Sarcoma and HIV-1-infection, run by AIDS Malignancy Consortium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Margaret Borok- Williams, MD (+263 (242) 791-631, mborok@mweb.co.zw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival at 48 weeks (time frame: 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05411237, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.

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