Kaposi SarcomaKS-CARENCT06480773
Kaposi Sarcoma Chemotherapy and Research (KS-CARE)
An observational study of Kaposi Sarcoma and HIV, run by UNC Lineberger Comprehensive Cancer Center at 2 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kaposi Sarcoma, HIV
- Type of treatment
- Injection or infusion
- How many people
- 127 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 25 Apr 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with human immunodeficiency virus (HIV)-associated Kaposi Sarcoma (HIV-KS) receiving treatment at Study Site
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
South Africa1 site
Stellenbosch University and Tygerberg Hospital
Cape Town, Stellenbosch, 8000
About this study
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
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
- Being tested
- standard of care chemotherapy
- Keywords
- Paclitaxel, Bleomycin, Vincristine, anti- retroviral
- Medical subject headings
- Sarcoma, Kaposi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard of care chemotherapyDrug
intravenous Paclitaxel or the combination of Bleomycin and Vincristine.
| Study group | Role | What they receive |
|---|---|---|
| HIV-associated Kaposi Sarcoma | Patients receive standard-of-care chemotherapy. Receives: Drug: standard of care chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
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.
Measured: Up to 48 weeks
Secondary outcomes (4)
Progression Free Survival (PFS) - 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.
Measured: Up to 96 weeks
Response rates (ORR)
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.
Measured: Up to 4 weeks
Overall Survival (OS)
OS will be defined as the time from chemotherapy treatment initiation until death.
Measured: Up to 96 weeks
Health-related Quality of Life (HR-QOL)
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.
Measured: Baseline, 4 weeks, 48 weeks, 76 weeks, 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start25 Apr 2023
- Primary completion31 Dec 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kaposi SarcomaStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Dirk Dittmer, PhD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06480773
- Sponsor's protocol ID
- KS-CARE
- Other IDs
- U54CA254564
- Acronym
- KS-CARE
- Status last verified
- Jan 2026
- First submitted
- 24 Jun 2024
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06480773
- Acronym / sponsor ID
- KS-CARE / KS-CARE
- Conditions
- Kaposi Sarcoma, HIV
- Keywords
- Paclitaxel, Bleomycin, Vincristine, anti- retroviral
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 127 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS), National Cancer Institute (NCI)
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV-associated Kaposi Sarcoma | – | Drug: standard of care chemotherapyPatients receive standard-of-care chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with human immunodeficiency virus (HIV)-associated Kaposi Sarcoma (HIV-KS) receiving treatment at Study Site
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard of care chemotherapyintravenous Paclitaxel or the combination of Bleomycin and Vincristine. | Drug | HIV-associated Kaposi Sarcoma |
Primary outcome
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.
4 secondary outcomes
Progression Free Survival (PFS) - 96 weeks
Time frame: Up to 96 weeks
Response rates (ORR)
Time frame: Up to 4 weeks
Overall Survival (OS)
Time frame: Up to 96 weeks
Health-related Quality of Life (HR-QOL)
Time frame: Baseline, 4 weeks, 48 weeks, 76 weeks, 96 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dirk Dittmer, PhD principal investigator
UNC Lineberger Comprehensive Cancer Center
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kaposi Sarcoma and HIV, run by UNC Lineberger Comprehensive Cancer Center at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Malawi, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: Up to 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.