Biomarkers in Blood Samples From Patients With HIV Infection and Stage III or Stage IV Hodgkin Lymphoma Undergoing Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01319526
Recruitment Status : Terminated (Parent protocol (SWOG S0816 / AMC-073) discontinued)
First Posted : March 21, 2011
Last Update Posted : October 5, 2015
National Cancer Institute (NCI)
The EMMES Corporation
Information provided by (Responsible Party):
AIDS Malignancy Consortium

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:



  • 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
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

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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).


  • 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."


  • No psychosocial conditions that would prevent study compliance and follow-up, as determined by the principal investigator
  • Willing to provide serial blood samples


  • See Disease Characteristics

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 identifier (NCT number): NCT01319526

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

Responsible Party: AIDS Malignancy Consortium 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:
HIV Infections
Hodgkin Disease
Neoplasms by Histologic Type
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