Paclitaxel and Pegylated Liposomal Doxorubicin for Treatment of HIV-related Kaposi Sarcoma
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAIDS Malignancy Consortium
About this trial
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 criteria
Qualifiers
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
20 or more skin and/or oral KS lesions, and/or
Disqualifiers
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%.
Trial design
Treatments tested in this trial
- Pegylated liposomal doxorubicin
- Paclitaxel
Treatment groups
130 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
AIDS Malignancy Consortium
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov