HIV Clinical Trial
Official title:
Investigating Chemotherapy Treatments, Response and Subsets of HIV-associated Kaposi Sarcoma in Malawi
NCT number | NCT03160183 |
Other study ID # | LCCC 1424 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 2016 |
Est. completion date | October 1, 2020 |
Verified date | December 2020 |
Source | UNC Lineberger Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is to identify important associations between complete and comprehensive clinical, laboratory, and genomic data derived from patients and tumor specimens, with prospectively recorded clinical outcomes. The investigators also hope to move beyond simple risk factor associations as previously described, to develop a composite score specifically for KS recurrence or progression, analogous to widely used risk scores that are used to direct up-front treatment of other cancers. In so doing, the investigators will draw on extremely granular data to prospectively identify patients who are most likely to benefit from new treatments.
Status | Completed |
Enrollment | 157 |
Est. completion date | October 1, 2020 |
Est. primary completion date | October 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Malawi | UNC Project | Lilongwe | |
Malawi | UNC Project, Lighthouse Trust | Lilongwe |
Lead Sponsor | Collaborator |
---|---|
UNC Lineberger Comprehensive Cancer Center | National Cancer Institute (NCI) |
Malawi,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | The clinical variables and laboratory biomarkers among HIV-associated KS patients and their possible association with response, PFS, and OS | The prevalence and nature of lymphoproliferative diseases among HIV-associated KS patients | 48 weeks | |
Other | The histopathology of KSHV-associated lymphoproliferative diseases among HIV-associated KS patients | KSHV gene expression characteristics for HIV-associated KS that develops on and off antiretroviral therapy (ART) | 48 weeks | |
Other | The kind of KSHV strains in tumor biopsies, PBMC and plasma | Viral genome features of HIV-associated KS | 48 weeks | |
Other | The KSHV gene expression characteristics between KS that develops on and off ART | To describe KSHV gene expression characteristics between KS that develops on and off ART | 48 weeks | |
Primary | Estimate the complete response rate (CR) at 48 weeks of HIV-associated KS patients overall and by BV treatment group. | the assessment of a patient's response (CR) to chemotherapy at 48 weeks by ACTG criteria | 48 weeks | |
Secondary | Estimate the Progression Free Survival (PFS) in HIV-associated KS patients overall and by bleomycin-vincristine (BV) treatment group | PFS which will be defined as the time from treatment initiation until disease progression or death | 48 weeks | |
Secondary | Estimate OS in HIV-associated KS patients overall and by BV treatment group | To estimate OS in HIV-associated KS patients overall and by BV treatment group | 48 weeks |
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