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Impact of ART Adherence on HIV Persistence and Inflammation

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ClinicalTrials.gov Identifier: NCT02797093
Recruitment Status : Active, not recruiting
First Posted : June 13, 2016
Last Update Posted : February 10, 2021
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date June 2, 2016
First Posted Date June 13, 2016
Last Update Posted Date February 10, 2021
Study Start Date January 2016
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 7, 2016)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 7, 2016)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Impact of ART Adherence on HIV Persistence and Inflammation
Official Title Impact of ART Adherence on HIV Persistence and Inflammation
Brief Summary The purpose of this study is to evaluate the relationship between anti-retroviral therapy (ART) adherence with levels of human immunodeficiency virus (HIV) reservoir and residual viremia in suppressed, HIV-infected individuals on chronic ART.
Detailed Description

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.

  1. 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).
  2. 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]
Study Design Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration 6 Months
Biospecimen Retention:   Samples With DNA
Description:
The aim of the study is to 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, the investigators will evaluate the changes in the HIV reservoir in relation to changes in ART adherence over time.
Sampling Method Non-Probability Sample
Study Population HIV-infected individuals who are being treated with a tenofovir-based regimen.
Condition Human Immunodeficiency Virus
Intervention Not Provided
Study Groups/Cohorts HIV suppressed individuals
HIV suppressed individuals on chronic ART, suboptimal adherence and exposure, measured through TFV-DP in DBS.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: June 7, 2016)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2021
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. HIV-infected males and females,
  2. Ages 18 years and older,
  3. Taking any TFV-based regimen,
  4. HIV suppression <20 copies/ml for at least 12 months;
  5. Not co-infected with HCV;
  6. Able and willing to give informed consent.

Exclusion Criteria:

  1. Pregnancy.
  2. Refusal to participate.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02797093
Other Study ID Numbers 15-2309
1R21AI124859-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of Colorado, Denver
Study Sponsor University of Colorado, Denver
Collaborators National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Jose R Castillo-Mancilla, MD University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date February 2021