Biomarkers in Blood Samples From Patients With HIV Infection and Stage III or Stage IV Hodgkin Lymphoma Undergoing Chemotherapy
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|ClinicalTrials.gov Identifier: NCT01319526|
Recruitment Status : Terminated (Parent protocol (SWOG S0816 / AMC-073) discontinued)
First Posted : March 21, 2011
Last Update Posted : October 5, 2015
RATIONALE: Studying samples of blood in the laboratory from patients undergoing treatment with HIV infection and Hodgkin lymphoma may help doctors learn more about the effects of therapy on HIV.
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.
|Condition or disease||Intervention/treatment|
|Lymphoma Nonneoplastic Condition||Genetic: DNA analysis Genetic: RNA analysis Other: laboratory biomarker analysis|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||1 participants|
|Official Title:||Quantification of HIV-1 Reservoirs in HIV-Positive Persons Receiving Response-Adapted Therapy for Stage III-IV Hodgkin Lymphoma: A Companion Protocol to SWOG Protocol S0816 (AMC-073)|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
- Change in viral load from baseline to each subsequent time point [ Time Frame: Baseline, after each cycle of treatment, restaging, treatment completion, year 1, year 2, study discontinuation ]Time frame for outcome measures dependent on study calendar for parent protocol, S0816, which varies by subject's PET scan status.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01319526
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|Principal Investigator:||John W. Mellors, MD||University of Pittsburgh|