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

Lymphoma Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01319526
• Other study ID #: AMC-079
• Secondary ID: CDR0000690149
• Status: Terminated
• Start date: June 2011
• Est. completion date: January 2013

Study information

• Verified date: July 2020
• Source: AIDS Malignancy Consortium
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma
• Nonneoplastic Condition

Intervention

Genetic:
• DNA analysis

• RNA analysis

Other:
• laboratory biomarker analysis

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
AIDS Malignancy Consortium	National Cancer Institute (NCI), The Emmes Company, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, after each cycle of treatment, restaging, treatment completion, year 1, year 2, study discontinuation