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

AIDS Malignancy Consortium

Status: Terminated

Conditions: Nonneoplastic Condition; Lymphoma

Treatments: Genetic: RNA analysis; Genetic: DNA analysis; Other: laboratory biomarker analysis

Study type: Observational

Funder types: NETWORK; Industry; NIH

Identifiers

NCT01319526

AMC-079

CDR0000690149 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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