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Active, Not Recruiting

NCT Number: NCT06480773

Kaposi Sarcoma Chemotherapy and Research (KS-CARE)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Kaposi Sarcoma DNA Virus Infections HIV Herpesviridae Infections Infections Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Vascular Tissue Sarcoma Sarcoma, Kaposi Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UNC Project, Kamuzu Central Hospital, Lilongwe, Malawi

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 with or without visceral disease. no evidence of improvement in human immunodeficiency virus (HIV)-associated Kaposi Sarcoma (HIV-KS) in the 4 weeks immediately prior; and a clinical indication for systemic chemotherapy treatment
  • Known HIV-1 infection status, as documented by any nationally approved, licensed HIV rapid test and confirmed at any time point prior by the local standard of care assay.
  • On ART or not on ART.
  • Age ≥18 years.
  • Participants able to understand and provide written informed consent in English, Afrikaans, or isiXhosa.

Exclusion criteria

Failure to meet the inclusion criteria listed above.

  • Specifically, pregnancy and breastfeeding are not exclusion criteria given the observational nature of the study with diagnostic and treatment interventions administered according to local standards of care.
  • Specifically, the absence of skin lesions is not an exclusion criterion if recorded evidence 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 human immunodeficiency virus (HIV)-associated Kaposi Sarcoma.
  • Specifically, patients who have had prior cART will not be excluded.
  • Participants who are receiving any other investigational agents.

Treatment and study plan

Standard of Care Chemotherapy

Drug

intravenous Paclitaxel or the combination of Bleomycin and Vincristine.

Primary outcomes

  1. Progression Free Survival (PFS)

    Time frame: Up to 48 weeks

    PFS will be defined as first chemotherapy day until disease progression. Mucocutaneous and visceral Human immunodeficiency virus (HIV)-associated Kaposi Sarcoma (HIV-KS) response will be assessed separately according to protocol-defined definitions. Mucocutaneous Progressive disease (mcPD) is defined as any increase or progression in the size, type and/or number of skin and/or mucosal lesions if present at baseline or new lesion. Visceral Progressive disease (vPD) is defined as any increase in symptoms related to visceral HIV-KS if present at baseline or a new manifestation of symptoms related to visceral HIV-KS, not present at baseline, or radiological or endoscopic evidence of visceral KS, not present at baseline. Notably, lymphoedema and nodal disease will not be part of the formal response assessment for CR, PR, and SD response criteria should have been maintained for at least 4 weeks. For PD response criteria can have been present for at least 1 week.

Secondary outcomes

  1. Progression Free Survival (PFS) - 96 weeks

    Time frame: Up to 96 weeks

    PFS will be defined as the time from chemotherapy treatment initiation until disease progression. Mucocutaneous and visceral Human immunodeficiency virus (HIV)-associated Kaposi Sarcoma (HIV-KS) response will be assessed separately according to protocol-defined definitions. Mucocutaneous Progressive disease (mcPD) is defined as any increase or progression in the size, type and/or number of skin and/or mucosal lesions if present at baseline or new lesion. Visceral Progressive disease (vPD) is defined as any increase in symptoms related to visceral HIV-KS if present at baseline or a new manifestation of symptoms related to visceral HIV-KS, not present at baseline, or radiological or endoscopic evidence of visceral KS, not present at baseline. Notably, lymphoedema and nodal disease will not be part of the formal response assessment for CR, PR, and SD response criteria should have been maintained for at least 4 weeks. For PD response criteria can have been present for at least 1 week.

  2. Response rates (ORR)

    Time frame: Up to 4 weeks

    Response rate will be assessed by Mucocutaneous and visceral Human immunodeficiency virus (HIV)-associated Kaposi Sarcoma (HIV-KS) separately according to protocol-defined definitions. ORR = Partial response (PR) or complete response (CR). Muco-Cutaneous Complete response (mcCR) is defined as the regression of all skin and/or mucosal lesions to hyperpigmented patches or macules if present at baseline. Muco-Cutaneous Partial response (mcPR) is defined as any reduction in the size, type and/or number of skin and/or mucosal lesions if present at baseline and no new manifestation of skin and/or mucosal lesions, not present at baseline. Visceral Complete response (vCR) is defined as the absence of symptomatic visceral KS if present at baseline. Visceral Partial response (vPR) is defined as any reduction in symptoms related to visceral HIV-KS if present at baseline and no new manifestation of symptoms related to visceral HIV-KS, not present at baseline.

  3. Overall Survival (OS)

    Time frame: Up to 96 weeks

    OS will be defined as the time from chemotherapy treatment initiation until death.

  4. Health-related Quality of Life (HR-QOL)

    Time frame: Baseline, 4 weeks, 48 weeks, 76 weeks, 96 weeks

    HR-QOL will be measured by validated Human immunodeficiency virus (HIV)-associated Kaposi Sarcoma (HIV-KS) Functional Assessment of HIV (FAHI) Quality of Life instrument with 3 supplemental questions addressing pain, swelling, and satisfaction with physical appearance (FAHI+KS) as developed by the National Institutes of Health, will be used to collect quality of life (QOL) data in 5 categories: physical well-being, emotional well-being, functional and global well-being, social well-being, and cognitive functioning. Items are rated by patients on a Likert scale from 0 to 4. Higher scores represent worse QOL.

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study 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

Acronym: KS-CARE

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jun 28, 2024
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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