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Paclitaxel and Pegylated Liposomal Doxorubicin for Treatment of HIV-related Kaposi Sarcoma | Clinical Trials | Clareo Health

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

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

NCT05411237•AIDS Malignancy Consortium

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+16 more criteria

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.
+1 more criteria

Key Dates

Start Date

September 1, 2026

Primary Completion Date

September 1, 2029

Completion Date

September 1, 2030

Last Updated

January 23, 2026

Enrollment

130

ESTIMATED participants

Conditions

Kaposi SarcomaHIV-1-infectionAIDS-related Kaposi Sarcoma

Interventions

Pegylated liposomal doxorubicin

DRUG

Paclitaxel

DRUG

Contacts

Margaret Borok- Williams, MD

CONTACT

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 23, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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