- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03160183
Investigating Chemotherapy Treatments, Response and Subsets of HIV-associated Kaposi Sarcoma in Malawi
Studieoversikt
Status
Forhold
Detaljert beskrivelse
This is a prospective, nonrandomized, open-label, single arm, cohort study of pathologically confirmed HIV-associated KS patients initiating chemotherapy in Malawi. The primary objective of this study is to estimate the complete response rate (CR by ACTG criteria) at 48 weeks. This will be done both overall and by chemotherapy (BV or not BV) treatment group. Secondary objectives are to estimate PFS and OS for both overall and by chemotherapy treatment group. Exploratory objectives include the investigation of: select clinical variables and laboratory biomarkers among HIV-associated KS patients and their possible association with response, PFS, and OS; the histopathology of KSHV-associated lymphoproliferative diseases among HIV-associated KS patients; KSHV strains in tumor biopsies, PBMC and plasma, and KSHV gene expression characteristics between KS that develops on and off ART.
The investigators plan to accrue 200 HIV-associated KS patients at a rate of approximately 50 patients per year. Approximately half of the patients will receive BV chemotherapy treatment. An important factor for this study's size is that it will be comparable to or exceed the size of other important KS cohort studies, which have demonstrated significant differences in outcomes based on gender or baseline KSHV DNA levels.
The investigators want to show that there are definable biologic and clinical subsets within the HIV-associated KS population, and that identifying these subsets will have direct relevance to more effective treatment strategies for these patients.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
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Lilongwe, Malawi
- UNC Project
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Lilongwe, Malawi
- UNC Project, Lighthouse Trust
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Histologically confirmed KS initiating chemotherapy at Lighthouse Trust or the Kamuzu Central Hospital (KCH) Cancer Clinic
- HIV positive (confirmed at any time point prior by local standard of care assay) on or off ART
- Age ≥18 years
- Residence <200 kilometers from KCH
- Able to understand and comply with study procedures for the entire length of the study
- Subject able to understand and provide written consent in English or Chichewa Informed consent reviewed and signed by patient
Exclusion Criteria:
- Failure to meet 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.
- KS relapse disease as defined by a prior KS diagnosis within 1 year prior to enrollment.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Estimate the complete response rate (CR) at 48 weeks of HIV-associated KS patients overall and by BV treatment group.
Tidsramme: 48 weeks
|
the assessment of a patient's response (CR) to chemotherapy at 48 weeks by ACTG criteria
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48 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Estimate the Progression Free Survival (PFS) in HIV-associated KS patients overall and by bleomycin-vincristine (BV) treatment group
Tidsramme: 48 weeks
|
PFS which will be defined as the time from treatment initiation until disease progression or death
|
48 weeks
|
Estimate OS in HIV-associated KS patients overall and by BV treatment group
Tidsramme: 48 weeks
|
To estimate OS in HIV-associated KS patients overall and by BV treatment group
|
48 weeks
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
The clinical variables and laboratory biomarkers among HIV-associated KS patients and their possible association with response, PFS, and OS
Tidsramme: 48 weeks
|
The prevalence and nature of lymphoproliferative diseases among HIV-associated KS patients
|
48 weeks
|
The histopathology of KSHV-associated lymphoproliferative diseases among HIV-associated KS patients
Tidsramme: 48 weeks
|
KSHV gene expression characteristics for HIV-associated KS that develops on and off antiretroviral therapy (ART)
|
48 weeks
|
The kind of KSHV strains in tumor biopsies, PBMC and plasma
Tidsramme: 48 weeks
|
Viral genome features of HIV-associated KS
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48 weeks
|
The KSHV gene expression characteristics between KS that develops on and off ART
Tidsramme: 48 weeks
|
To describe KSHV gene expression characteristics between KS that develops on and off ART
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48 weeks
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Dirk Dittmer, UNC-CH
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- LCCC 1424
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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