Collecting Blood and Tissue Sample Donations for Research for HIV/AIDS-Related Cancers
Recruitment Status: Recruiting
Start Date: May 10, 2023
End Date: August 31, 2035
Inclusion Criteria:
- Participants must be at least 18 years of age
- Participant must be HIV- positive and have a diagnosed malignancy. If participants are HIV-negative, they must have a newly diagnosed or recurrent malignancy that has an established scientific connection (e.g., shared etiology) to an AIDS- associated malignancy such as:
- classic Kaposi sarcoma
- transplant-associated Kaposi sarcoma,
- anal cancer,
- multicentric Castleman's disease,
- Epstein Barr Virus (EBV) -positive lymphoma
- plasmablastic lymphoma
- Hodgkin's lymphoma.
- For participants that are HIV-positive, HIV infection must be documented by means of any one of the following: :
- Documentation of HIV diagnosis in the medical record by a licensed health care provider;
- Documentation of receipt of antiretroviral therapy (ART) by a licensed health care provider (Documentation may be a record of an ART prescription in the participant's medical record, a written prescription in the name of the participant for ART, or pill bottles for ART with a label showing the participant's name. Receipt of at least two agents is required; each component agent of a multi-class combination ART regimen will be counted toward the 2-agent requirement, excepting receipt of a pre-exposure prophylaxis (PrEP) regimen alone [e.g., Truvada], which is exclusionary);
- HIV ribonucleic acid (RNA) detection by a licensed HIV RNA assay demonstrating > 1000 RNA copies/mL;
- Any licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV Western blot confirmation or HIV rapid multispot antibody differentiation assay.
- Participants with HIV infection, regardless of participation in an AMC clinical trial, must have a diagnosis of cancer, cancer or a condition that places them at a higher risk of cancer.
- The investigator determines that the participant (or his/her legally authorized representative [LAR]) has the ability to provide informed consent and the participant or LAR provides written informed consent.