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

Results pending

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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Recruitment Status

TERMINATED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lymphoma Nonneoplastic Condition

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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DNA analysis

Intervention Type GENETIC

RNA analysis

Intervention Type GENETIC

laboratory biomarker analysis

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

The Emmes Company, LLC

INDUSTRY

Sponsor Role collaborator

AIDS Malignancy Consortium

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Boston Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

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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