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Kaposi Sarcoma Chemotherapy and Research (KS-CARE)
Sponsor: UNC Lineberger Comprehensive Cancer Center
Summary
This prospective, nonrandomized, open-label, single-arm, cohort study examines the effects of chemotherapy provided under local standard of care in patients with pathologically confirmed HIV-associated Kaposi Sarcoma (HIV-KS). Previous HIV-KS studies demonstrated significant variability in clinical outcomes based on differences in gender or baseline KSHV DNA levels in patients with HIV-KS. Patients will receive chemotherapy according to local site treatment guidelines and standard of care. Chemotherapy regimen for two treatments that are used locally based on physician's choice namely intravenous (IV) Paclitaxel (PTX) or the combination of Bleomycin and Vincristine (BV). In addition, all histologically proven HIV-KS could be enrolled, irrespective of their prior length of combination anti-retroviral treatment (cART). This enrolment strategy will reflect a more realistic picture of HIV-KS management. This study result could trigger treatment alteration of HIV-KS. The treatment approaches to HIV-KS can be individualized if clinically relevant subsets and novel prognostic markers are defined. In that case, newer and potentially more expensive agents can be selectively applied to those patients most likely to benefit, especially if prolonged treatment is needed.
Official title: Kaposi Sarcoma Chemotherapy and Research (KS-CARE): Clinical and Molecular Determinants of HIV-associated Kaposi Sarcoma Progression Under Local Standard-of-care Therapy in Malawi and South Africa
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
127
Start Date
2023-04-25
Completion Date
2026-12-31
Last Updated
2026-02-05
Healthy Volunteers
No
Conditions
Interventions
standard of care chemotherapy
intravenous Paclitaxel or the combination of Bleomycin and Vincristine.
Locations (2)
UNC Project, Kamuzu Central Hospital
Lilongwe, Malawi
Stellenbosch University and Tygerberg Hospital
Cape Town, Stellenbosch, South Africa