Impact of ART Adherence on HIV Persistence and Inflammation
|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: NCT02797093|
Recruitment Status : Recruiting
First Posted : June 13, 2016
Last Update Posted : May 23, 2018
|Condition or disease|
|Human Immunodeficiency Virus|
Understanding whether the size and dynamics of the HIV reservoir are associated with adherence, measured by an objective biomarker, could have significant clinical and therapeutic implications for ART and HIV cure.
- First, this aim will quantify levels of CA-RNA, CA-DNA, and plasma residual viremia in suppressed, HIV infected individuals and correlate them with levels of TFV-DP in DBS as a measure of cumulate drug exposure (adherence).
- Second, this study will evaluate the changes in the HIV reservoir in relation to changes in ART adherence over time.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||100 participants|
|Observational Model:||Ecologic or Community|
|Target Follow-Up Duration:||6 Months|
|Official Title:||Impact of ART Adherence on HIV Persistence and Inflammation|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||March 2019|
HIV suppressed individuals
HIV suppressed individuals on chronic ART, suboptimal adherence and exposure, measured through TFV-DP in DBS.
- Level of tenofovir diphosphate in dried blood spots associated with the size of the HIV reservoir measured by the amount of CA-RNA and CA-DNA in PBMCs. [ Time Frame: 6 months ]Evaluation of variations in ART cumulative adherence are associated with the size of the HIV reservoir and with the degree of chronic inflammation and immune activation in HIV-infected, virologically suppressed individuals.
- Level of self-reported adherence (4-day, 30-day and 3-months using a visual analog scale) associated with the size of the HIV reservoir measured by CA-RNA and CA-DNA in PBMCs. [ Time Frame: 6 months ]Evaluation of variations in ART self-reported adherence are associated with the size of the HIV reservoir and with the degree of chronic inflammation and immune activation in HIV-infected, virologically suppressed individuals.
Biospecimen Retention: Samples With DNA
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): NCT02797093
|Contact: Ryan Coylefirstname.lastname@example.org|
|United States, Colorado|
|University of Colorado, Denver||Recruiting|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Jose R Castillo-Mancilla, MD||University of Colorado, Denver|