IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
Biomarkers in Blood Samples From Patients With HIV Infection and Stage III or Stage IV Hodgkin Lymphoma Undergoing Chemotherapy
This study has been terminated.
(Parent protocol (SWOG S0816 / AMC-073) discontinued)
Sponsor:
AIDS Malignancy Consortium
Collaborators:
National Cancer Institute (NCI)
The EMMES Corporation
Information provided by (Responsible Party):
AIDS Malignancy Consortium
ClinicalTrials.gov Identifier:
NCT01319526
First received: December 18, 2010
Last updated: October 1, 2015
Last verified: October 2015
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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) |
Resource links provided by NLM:
Further study details as provided by AIDS Malignancy Consortium:
Primary Outcome Measures:
- 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 ]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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| 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).
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01319526
Please refer to this study by its ClinicalTrials.gov identifier: NCT01319526
Locations
| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231-2410 | |
Sponsors and Collaborators
AIDS Malignancy Consortium
National Cancer Institute (NCI)
The EMMES Corporation
Investigators
| Principal Investigator: | John W. Mellors, MD | University of Pittsburgh |
More Information
| Responsible Party: | AIDS Malignancy Consortium |
| ClinicalTrials.gov Identifier: | NCT01319526 History of Changes |
| Other Study ID Numbers: |
AMC-079 CDR0000690149 ( Other Identifier: NCI ) |
| Study First Received: | December 18, 2010 |
| Last Updated: | October 1, 2015 |
Keywords provided by AIDS Malignancy Consortium:
|
stage III adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma HIV infection |
Additional relevant MeSH terms:
|
Lymphoma HIV Infections Hodgkin Disease Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes |
ClinicalTrials.gov processed this record on June 23, 2017