Clinical trial NCT01319526: Biomarkers in Blood Samples From Patients With HIV Infection and Stage III or Stage IV Hodgkin Lymphoma Undergoing Chemotherapy
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 type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lymphoma
Nonneoplastic Condition
Keywords: stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
HIV infection
Lead sponsor: AIDS Malignancy Consortium
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
name: The Emmes Company, LLC
First posted: 2011-03-21
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Change in viral load from baseline to each subsequent time point
timeFrame: Baseline, after each cycle of treatment, restaging, treatment completion, year 1, year 2, study discontinuation
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: University of Pittsburgh
name: John W. Mellors, MD
role: PRINCIPAL_INVESTIGATOR
References: