Biomarkers in Blood Samples From Patients With HIV Infection and Stage III or Stage IV Hodgkin Lymphoma Undergoing Chemotherapy
NCT ID: NCT01319526
Last Updated: 2020-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
1 participants
OBSERVATIONAL
2011-06-30
2013-01-31
Brief Summary
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PURPOSE: This research study is studying biomarkers in blood samples from patients with HIV infection and stage III or stage IV Hodgkin lymphoma undergoing chemotherapy.
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Detailed Description
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Primary
* To quantify HIV-1 persistence in prospectively collected samples from patients on suppressive antiretroviral therapy undergoing chemotherapy for Hodgkin lymphoma.
OUTLINE: This is a multicenter study.
Blood samples are collected before, during, and after treatment for lymphoma for HIV-1 RNA levels using standard and single copy assays and HIV-1 DNA quantification (peripheral blood mononuclear cells).
After completion of treatment, patients are followed up periodically for up to 2 years.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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DNA analysis
RNA analysis
laboratory biomarker analysis
Eligibility Criteria
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Inclusion Criteria
* HIV-1 infection, as documented by a rapid HIV test or any FDA-approved HIV-1 enzyme or chemiluminescence immunoassay (E/CIA) test kit and confirmed by western blot at any time prior to study entry
* Documentation may be serologic (positive ELISA and positive western blot), or other federally approved licensed HIV diagnostic test
* Prior documentation of HIV seropositivity is acceptable
* Diagnosis of untreated Hodgkin lymphoma and participation in the parent protocol SWOG-S0816, "A Phase II Trial of Response Adapted Therapy of Stage III-IV Hodgkin Lymphoma Using Early Interim FDG-PET Imaging."
PATIENT CHARACTERISTICS:
* No psychosocial conditions that would prevent study compliance and follow-up, as determined by the principal investigator
* Willing to provide serial blood samples
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
The Emmes Company, LLC
INDUSTRY
AIDS Malignancy Consortium
NETWORK
Responsible Party
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Principal Investigators
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John W. Mellors, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
Countries
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Other Identifiers
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CDR0000690149
Identifier Type: OTHER
Identifier Source: secondary_id
AMC-079
Identifier Type: -
Identifier Source: org_study_id
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