Paclitaxel and Pegylated Liposomal Doxorubicin for Treatment of HIV-related Kaposi Sarcoma

NCT05411237 | Not Yet Recruiting Phase 3 DMC

• 2 other identifiers: AMC-114U01CA121947
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Kaposi Sarcoma; HIV-1-infection; AIDS-related Kaposi Sarcoma

Keywords

Paclitaxel; Pegylated liposomal doxorubicin; AIDS associated Kaposi Sarcoma; Human Immunodeficiency Virus; HIV-related Kaposi Sarcoma

Outcome Measures

Primary Outcomes (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

  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.

  96 weeks

• Objective response rate for AIDS-related KS in patients receiving PLD and PTX

  96 weeks

• Duration of Response in patients receiving PLD and PTX

  96 weeks

Study Arms (2)

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.

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.

Drug: Paclitaxel

Interventions

Pegylated liposomal doxorubicin DRUG

PLD 20 mg/m2 on Day 1 of every 21-day cycle

Also known as: Doxil

Pegylated Liposomal Doxorubicin

Paclitaxel DRUG

PTX 100 mg/m2 on Day 1 of every 21-day cycle

Also known as: Taxol

Paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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).
• 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:

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• AIDS Malignancy Consortium: lead
• National Cancer Institute (NCI): collaborator

Related Publications (1)

• 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.

  PMID: 41286911 DERIVED

MeSH Terms

Conditions

Sarcoma, Kaposi; AIDS-related Kaposi sarcoma; Acquired Immunodeficiency Syndrome

Interventions

liposomal doxorubicin; Paclitaxel

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Susan Krown, MD

  AIDS Malignancy Consortium

  STUDY CHAIR

Central Study Contacts

Margaret Borok- Williams, MD

CONTACT

+263 (242) 791-631; mborok@mweb.co.zw

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: June 9, 2022
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2030
• Last Updated: January 23, 2026

Record last verified: 2026-01