Biomarkers in Blood Samples From Patients With HIV Infection and Stage III or Stage IV Hodgkin Lymphoma Undergoing Chemotherapy
|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|
|Primary Completion Date :||January 2013|
|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
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|