| 1.HIV-1 infection.
2.Histologically confirmed KS prior to study entry, confirmed by an AMC-certified pathologist.
3.Current stage T1 KS (irrespective of prior treatment with 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.
4. Men and women ≥ 18 years. Persons <18 years of age 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.
8.Participants may be ART-naïve or ART-experienced but must be able to receive an ART regimen.
9.Measurable cutaneous KS as defined in protocol.
10.The following laboratory values obtained within 14 days prior to study entry:
-Absolute Neutrophil Count ≥ 1000 cells/mm3.
-Hemoglobin ≥ 8 g/dL.
-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.
11.Women of reproductive potential must have a -ve pregnancy test done within 24 hours of initiating the protocol chemotherapy.
12.Participants must agree to use two reliable forms of contraception simultaneously while receiving protocol-specified medication and for 6 months after stopping the medication.
11.Adequate venous access.
12.No prior chemotherapy or use of systemic cytotoxic therapy agents.
13.Participant is able and willing to sign ICF |
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.
11.Patients with psychiatric illness and/or social circumstances that would limit compliance with study requirements. |
80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) |
18 Year(s) |
200 Year(s) |
Both |