Ignite Creation Date:
2024-05-06 @ 10:16 AM
Last Modification Date:
2024-10-26 @ 12:27 PM
Study NCT ID:
NCT03215004
Status:
UNKNOWN
Last Update Posted:
2020-09-16
First Post:
2017-07-07
Brief Title:
Developing a Functional Cure for HIV Disease Clinical Specimen Collection From HIV Positive Individuals
Sponsor:
American Gene Technologies International Inc
Organization:
American Gene Technologies International Inc
Study Overview
Official Title:
Developing a Functional Cure for HIV Disease Clinical Specimen Collection From HIV Positive Individuals
Status:
UNKNOWN
Status Verified Date:
2020-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 facilitys 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 GCPICH 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
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 GCPICH 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None