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)
Verified date | July 2020 |
Source | AIDS Malignancy Consortium |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland |
United States | Boston Medical Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
AIDS Malignancy Consortium | National Cancer Institute (NCI), The Emmes Company, LLC |
United States,
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 |
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