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New study aims to personalize chemo for HIV-Linked cancer

NCT ID NCT06480773

Knowledge-focused Sponsor: UNC Lineberger Comprehensive Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 127 people with HIV-related Kaposi sarcoma in Malawi and South Africa who are receiving standard chemotherapy (paclitaxel or bleomycin plus vincristine). Researchers want to understand why some patients respond better than others, looking at factors like gender and virus levels. The goal is to find ways to tailor treatment for better outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Paclitaxel or Bleomycin and Vincristine (chemotherapy)
What this could lead to
If successful, this study could help doctors personalize chemotherapy for HIV-related Kaposi sarcoma, potentially improving outcomes and reducing side effects.
What could go wrong
This is an observational study, not testing a new treatment. It may not lead to immediate changes in care, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

127 people

The number who actually took part.

Started

Apr 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Subjects with human immunodeficiency virus (HIV)-associated Kaposi Sarcoma (HIV-KS) receiving treatment at Study Site

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

HIV infectious disease Kaposi's sarcoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV Kaposi sarcoma

Contacts and locations

Locations

  • Stellenbosch University and Tygerberg Hospital

    Cape Town, Stellenbosch, 8000, South Africa

  • UNC Project, Kamuzu Central Hospital

    Lilongwe, Malawi

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