Developing a Functional Cure for HIV Disease: Clinical Specimen Collection From HIV Positive Individuals
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03215004|
Recruitment Status : Recruiting
First Posted : July 12, 2017
Last Update Posted : January 9, 2019
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||24 participants|
|Official Title:||Developing a Functional Cure for HIV Disease: Clinical Specimen Collection From HIV Positive Individuals|
|Actual Study Start Date :||July 25, 2017|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
- Collection of clinical specimens [ Time Frame: up to 120 days ]The blood samples collected will be tested to measure the absolute and relative levels of CD4+ and CD8+ T cells. Data will describe the range of CD4+ T cell and CD8+ T cell responses to peptide stimulation. The samples will also help validate the assays and processes for the development of the cell product to be used in a future clinical trial.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03215004
|United States, District of Columbia|
|Washington, District of Columbia, United States, 20017|
|Contact: Gerome Burke, M.D., Ph.D. 202-854-4310 gburk004@AscensionHealth.onmicrosoft.com|