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

N/ATerminatedNCT01319526

AIDS Malignancy Consortium1 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Lymphoma Nonneoplastic Condition

Interventions

DNA analysisGENETIC

RNA analysisGENETIC

laboratory biomarker analysisOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Boston Medical Center

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Change in viral load from baseline to each subsequent time point

Time frame for outcome measures dependent on study calendar for parent protocol, S0816, which varies by subject's PET scan status.

Time frame: Baseline, after each cycle of treatment, restaging, treatment completion, year 1, year 2, study discontinuation

Data from ClinicalTrials.gov

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