HIV Infections Clinical Trial
Official title:
Developing a Functional Cure for HIV Disease: Clinical Specimen Collection From HIV Positive Individuals
Clinical specimens are required from HIV positive individuals with viremia controlled by antiretroviral therapy to complete process development for a genetically modified autologous T cell product, AGT103-T. The product will be used in a subsequent early stage clinical trial in subjects with chronic HIV disease and viremia suppressed by antiretroviral therapy as the initial step in testing a functional cure for HIV disease. Enrolled participants provide a venous blood specimen (approximately 25mL) to determine their level of HIV-reactive CD4+ T cells. Subjects with positive T cell responses will be asked to undergo leukapheresis and their clinical specimens will be used to validate and qualify the AGT103-T cell product.
This protocol is to collect blood specimens from HIV positive individuals. The first blood
draw will be done at the first study visit and if eligible, the second blood collection will
be done via leukapheresis at the second visit. The leukapheresis procedures will follow the
facility's standard operating procedures and protocol requirements for leukapheresis.
Volunteers will be males or females between and including the ages of 18 years and 60 years.
Volunteers will provide written informed consent and meet all inclusion and exclusion
criteria. Each participant can be in the study for up to 120 days (3 months).
The study will be conducted in accordance with GCP/ICH for human research for the purposes of
obtaining clinical specimens for research. There is no endpoint for this study, however, data
collected from this study will include, but not be limited to, gender, demographics, medical
history, clinical laboratory values, and volume of the blood collected. The data will be
summarized in future studies reporting results from a planned clinical trial.
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