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)

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01319526

Enrollment

Registered

2011-03-21

Start date

2011-06-30

Completion date

2013-01-31

Last updated

2020-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma, Nonneoplastic Condition

Keywords

stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma, HIV infection

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.

Interventions

GENETICDNA analysis

GENETICRNA analysis

OTHERlaboratory biomarker analysis

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
Change in viral load from baseline to each subsequent time point	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026