Small study tracks daily life impact of kaposi sarcoma treatment
NCT ID NCT03596918
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study followed 10 people with HIV and AIDS-related Kaposi sarcoma in Tanzania to see how their quality of life changed during treatment with vincristine and bleomycin. Participants filled out questionnaires about their physical, emotional, social, and daily functioning over several months. The goal was to understand how the cancer and its treatment affect well-being, not to test a new cure.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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10 people
The number who actually took part.
- Started
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Oct 2018
- Finished
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Jun 2020
- Lead sponsor
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A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Participants will be selected from the clinical care population presenting to Bugando Medical Center.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 ribonucleic acid (RNA) viral load * NOTE: the term "licensed" refers to a United States (U.S.) FDA-approved kit or for sites located in countries other than the U.S., a kit that has been certified or licensed by an oversight body within that country and validated internally * World Health Organization (WHO) and Centers for Disease Control and Prevention (CDC) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment; a reactive initial rapid test should be confirmed by either another type of rapid assay or an E/CIA that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), or a Western blot or a plasma HIV-1 ribonucleic acid (RNA) viral load * Participants must have pathologically confirmed Kaposi sarcoma * Participants should not have had prior therapy for their Kaposi sarcoma * All participants must be on stable antiretroviral therapy (ART) for a minimum of 12 weeks prior to study entry with an acceptable regimen that adheres to national guidelines for treatment of HIV infection * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky performance status \>= 50%) * Leukocytes: \>= 3,000/mm\^3, within 7 days of enrollment * Absolute neutrophil count: \>= 1,000/mm\^3, within 7 days of enrollment * Hemoglobin \>= 8 g/dL, within 7 days of enrollment * Platelets: \>= 75,000/mm\^3, within 7 days of enrollment * Direct bilirubin: \< 3 mg/dL, within 7 days of enrollment * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) / alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]): =\< 2.5 x institutional upper limit of normal, within 7 days of enrollment * Creatinine: * Creatinine levels within normal institutional limits, within 7 days of enrollment; or, * Creatinine clearance \>= 60 mL/min/1.73 m\^2 for participants with creatinine levels above institutional normal, within 7 days of enrollment * Participants with serious chronic, acute, or recurrent infections must have completed at least 14 days of therapy prior to study entry and be clinically stable * If the participant is a female of childbearing potential (FCBP), defined as a sexually mature woman who: (1) has not undergone a hysterectomy or bilateral oophorectomy, or (2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months), the participant must have a negative urine or serum pregnancy test within 1 week prior to enrollment and agree to use an effective form of contraception (e.g., barrier contraception or hormonal contraception), during the 5 months of planned chemotherapy treatment and for 6 months after completing treatment * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Participants who are receiving any other investigational agents * Participants with known brain metastases * History of allergic reactions attributed to compounds of similar chemical or biologic composition to bleomycin or vincristine * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Participants who are breastfeeding a child; breastfeeding should be discontinued if the mother is treated with this chemotherapy * Current or history of known pulmonary fibrosis, chronic obstructive pulmonary disease (COPD), emphysema, bronchiectasis, or diffuse or significant local radiographic interstitial infiltrates on chest x-ray (CXR) or computed axial tomography (CT) scan, that, in the opinion of the investigator, would exclude bleomycin use * NOTE: participants with an abnormal CXR or CT scan (which may indicate pulmonary KS) should undergo screening evaluations to rule out an infectious cause, per standard of care; if available, other diagnostic procedures such as bronchoscopy should be considered to confirm the presence or absence of pulmonary KS and/or an infectious agent; these procedures should be completed outside the study; these participants should be excluded if, in the opinion of the site investigator, use of bleomycin would be detrimental * Oxygen saturation less than 90% and/or exercise desaturation greater than 4% within 14 days before study enrollment * NOTE: exercise is defined as any activity that will increase a participant?s resting heart rate by at least 20 beats/minute
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Bugando Medical Centre
Mwanza, Tanzania
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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