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

Sponsor:

Collaborators:

National Cancer Institute (NCI)

The EMMES Corporation

Information provided by (Responsible Party):

AIDS Malignancy Consortium

Study Description

Brief Summary:

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

Detailed Description:

OBJECTIVES:

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.

Study Design


Study Type :	Observational
Actual Enrollment :	1 participants
Observational Model:	Cohort
Time Perspective:	Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Hodgkin Disease Lymphoma

Genetic and Rare Diseases Information Center resources: Lymphosarcoma Hodgkin Lymphoma

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

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

PBMC

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Clinical trial participants (subjects who are participating in parent protocol S0816 and provide informed consent for participation in this substudy).

Criteria

DISEASE CHARACTERISTICS:

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

Contacts and Locations

Information from the National Library of Medicine

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

Locations


United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410

Sponsors and Collaborators

AIDS Malignancy Consortium

National Cancer Institute (NCI)

The EMMES Corporation

Investigators


Principal Investigator:	John W. Mellors, MD	University of Pittsburgh

More Information


Responsible Party:	AIDS Malignancy Consortium
ClinicalTrials.gov Identifier:	NCT01319526 History of Changes
Other Study ID Numbers:	AMC-079 CDR0000690149 ( Other Identifier: NCI )
First Posted:	March 21, 2011 Key Record Dates
Last Update Posted:	October 5, 2015
Last Verified:	October 2015

Keywords provided by AIDS Malignancy Consortium:


stage III adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma HIV infection

Additional relevant MeSH terms:


Lymphoma HIV Infections Hodgkin Disease Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders	Immune System Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes

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