Biomarkers in Blood Samples From Patients With HIV Infection and Stage III or Stage IV Hodgkin Lymphoma Undergoing Chemotherapy
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Lymphoma Nonneoplastic Condition |
Genetic: DNA analysis Genetic: RNA analysis Other: laboratory biomarker analysis |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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) |
- Change in viral load from baseline to each subsequent time point [ Time Frame: Baseline, after each cycle of treatment, restaging, treatment completion, year 1, year 2, study discontinuation ] [ Designated as safety issue: No ]Time frame for outcome measures dependent on study calendar for parent protocol, S0816, which varies by subject's PET scan status.
Biospecimen Retention: Samples With DNA
PBMC
| Enrollment: | 1 |
| Study Start Date: | June 2011 |
| Study Completion Date: | January 2013 |
| Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Clinical trial participants (subjects who are participating in parent protocol S0816 and provide informed consent for participation in this substudy).
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01319526
| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231-2410 | |
| Principal Investigator: | John W. Mellors, MD | University of Pittsburgh |
More Information
No publications provided
| Responsible Party: | AIDS Malignancy Clinical Trials Consortium |
| ClinicalTrials.gov Identifier: | NCT01319526 History of Changes |
| Other Study ID Numbers: | AMC-079, CDR0000690149 |
| Study First Received: | December 18, 2010 |
| Last Updated: | August 27, 2014 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by AIDS Malignancy Clinical Trials Consortium:
|
stage III adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma HIV infection |
Additional relevant MeSH terms:
|
Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases |
Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on March 03, 2015