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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)


N/A
18 Years
N/A
Not Enrolling
Both
Lymphoma, Nonneoplastic Condition

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Trial Information

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)


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.

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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Change in viral load from baseline to each subsequent time point

Outcome Description:

Time frame for outcome measures dependent on study calendar for parent protocol, S0816, which varies by subject's PET scan status.

Outcome Time Frame:

Baseline, after each cycle of treatment, restaging, treatment completion, year 1, year 2, study discontinuation

Safety Issue:

No

Principal Investigator

John W. Mellors, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh

Authority:

United States: Federal Government

Study ID:

CDR0000690149

NCT ID:

NCT01319526

Start Date:

June 2011

Completion Date:

January 2013

Related Keywords:

  • Lymphoma
  • Nonneoplastic Condition
  • stage III adult Hodgkin lymphoma
  • stage IV adult Hodgkin lymphoma
  • HIV infection
  • HIV Infections
  • Hodgkin Disease
  • Lymphoma

Name

Location

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410