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

This study has been terminated.
(Parent protocol (SWOG S0816 / AMC-073) discontinued)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
AIDS Malignancy Clinical Trials Consortium
ClinicalTrials.gov Identifier:
NCT01319526
First received: December 18, 2010
Last updated: January 7, 2013
Last verified: January 2013

December 18, 2010
January 7, 2013
June 2011
January 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Time frame for outcome measures dependent on study calendar for parent protocol, S0816, which varies by subject's PET scan status.
Change in viral load from baseline to each subsequent time point [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01319526 on ClinicalTrials.gov Archive Site
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Biomarkers in Blood Samples From Patients With HIV Infection and Stage III or Stage IV Hodgkin Lymphoma Undergoing Chemotherapy
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)

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

PBMC

Non-Probability Sample

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

  • Lymphoma
  • Nonneoplastic Condition
  • Genetic: DNA analysis
  • Genetic: RNA analysis
  • Other: laboratory biomarker analysis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
January 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01319526
CDR0000690149, AMC-079
No
AIDS Malignancy Clinical Trials Consortium
AIDS Malignancy Clinical Trials Consortium
National Cancer Institute (NCI)
Principal Investigator: John W. Mellors, MD University of Pittsburgh
AIDS Malignancy Clinical Trials Consortium
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP