NCT06480773

Kaposi Sarcoma Chemotherapy and Research (KS-CARE)

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 127 (actual)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kaposi Sarcoma
• HIV

Interventions

Type	Name	Description
DRUG	standard of care chemotherapy	intravenous Paclitaxel or the combination of Bleomycin and Vincristine.

Timeline

• Start date: 2023-04-25
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2024-06-28
• Last updated: 2026-02-05

Locations

2 sites across 2 countries: Malawi, South Africa