- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03160183
Investigating Chemotherapy Treatments, Response and Subsets of HIV-associated Kaposi Sarcoma in Malawi
Studieoversigt
Status
Betingelser
Detaljeret 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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
-
Lilongwe, Malawi
- UNC Project
-
Lilongwe, Malawi
- UNC Project, Lighthouse Trust
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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 undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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
|
48 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
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
|
48 weeks
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Dirk Dittmer, UNC-CH
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- LCCC 1424
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med HIV
-
University of Alabama at BirminghamMobile County Health Deparment; Alabama Department of Public HealthRekrutteringHIV | HIV-testning | HIV-kobling til pleje | HIV behandlingForenede Stater
-
French National Agency for Research on AIDS and...Elizabeth Glaser Pediatric AIDS FoundationAfsluttetPartner HIV-testning | Par HIV Rådgivning | Parkommunikation | HIV-forekomstCameroun, Dominikanske republik, Georgien, Indien
-
ANRS, Emerging Infectious DiseasesHopital Universitaire Robert-Debre; Institut de Recherche pour le Developpement og andre samarbejdspartnereUkendtHIV | HIV-uinficerede børn | Børn udsat for HIVCameroun
-
University of MinnesotaTrukket tilbageHIV-infektioner | HIV/AIDS | Hiv | AIDS | Aids/Hiv problem | AIDS og infektionerForenede Stater
-
Erasmus Medical CenterIkke rekrutterer endnuHIV-infektioner | Hiv | HIV-1-infektion | HIV I infektionHolland
-
Hospital Clinic of BarcelonaAfsluttetIntegrasehæmmere, HIV; HIV PROTEASE HÆMMERSpanien
-
University of Maryland, BaltimoreTrukket tilbageHiv | Nyretransplantation | HIV reservoir | CCR5Forenede Stater
-
Africa Health Research InstituteLondon School of Hygiene and Tropical Medicine; University College, London og andre samarbejdspartnereRekrutteringHIV | HIV-testning | Tilknytning til plejeSydafrika
-
National Taiwan UniversityRekruttering
-
Helios SaludViiV HealthcareUkendtHiv | HIV-1-infektionArgentina