Kaposi Sarcoma Chemotherapy and Research (KS-CARE)

Last updated: July 7, 2025
Sponsor: UNC Lineberger Comprehensive Cancer Center
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Kaposi's Sarcoma

Hiv

Sarcoma

Treatment

standard of care chemotherapy

Clinical Study ID

NCT06480773
KS-CARE
U54CA354640
3U54CA254564
U54CA254564
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Participants meeting all the inclusion criteria listed below will be eligible for screening.

  • Histologically confirmed T1 KS presenting to TBH combined Kaposi Sarcoma clinic withor without visceral disease. no evidence of improvement in human immunodeficiencyvirus (HIV)-associated Kaposi Sarcoma (HIV-KS) in the 4 weeks immediately prior; anda clinical indication for systemic chemotherapy treatment

  • Known HIV-1 infection status, as documented by any nationally approved, licensed HIVrapid test and confirmed at any time point prior by the local standard of careassay.

  • On ART or not on ART.

  • Age ≥18 years.

  • Participants able to understand and provide written informed consent in English,Afrikaans, or isiXhosa.

Exclusion

Exclusion Criteria:

Failure to meet the inclusion criteria listed above.

  • Specifically, pregnancy and breastfeeding are not exclusion criteria given theobservational nature of the study with diagnostic and treatment interventionsadministered according to local standards of care.

  • Specifically, the absence of skin lesions is not an exclusion criterion if recordedevidence of

  • visceral or nodal disease is present in the form of a radiology or endoscopy report.

  • Participants who have had prior chemotherapy or radiotherapy for humanimmunodeficiency virus (HIV)-associated Kaposi Sarcoma.

  • Specifically, patients who have had prior cART will not be excluded.

  • Participants who are receiving any other investigational agents.

Study Design

Total Participants: 127
Treatment Group(s): 1
Primary Treatment: standard of care chemotherapy
Phase:
Study Start date:
April 25, 2023
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • UNC Project, Kamuzu Central Hospital

    Lilongwe,
    Malawi

    Site Not Available

  • Stellenbosch University and Tygerberg Hospital

    Cape Town, Stellenbosch 8000
    South Africa

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.