We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Impact of ART Adherence on HIV Persistence and Inflammation

This study is currently recruiting participants.
Verified October 2017 by University of Colorado, Denver
Sponsor:
ClinicalTrials.gov Identifier:
NCT02797093
First Posted: June 13, 2016
Last Update Posted: October 26, 2017
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.
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
University of Colorado, Denver
  Purpose
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.

Condition
Human Immunodeficiency Virus

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Impact of ART Adherence on HIV Persistence and Inflammation

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
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.

Estimated Enrollment: 100
Study Start Date: January 2016
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
HIV suppressed individuals
HIV suppressed individuals on chronic ART, suboptimal adherence and exposure, measured through TFV-DP in DBS.

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV-infected individuals who are being treated with a tenofovir-based regimen.
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.
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Ryan Coyle 303-408-3042 ryan.coyle@ucdenver.edu

Locations
United States, Colorado
University of Colorado, Denver Recruiting
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Jose R Castillo-Mancilla, MD University of Colorado, Denver
  More Information

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02797093     History of Changes
Other Study ID Numbers: 15-2309
1R21AI124859-01 ( U.S. NIH Grant/Contract )
First Submitted: June 2, 2016
First Posted: June 13, 2016
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Colorado, Denver:
anti-retroviral therapy

Additional relevant MeSH terms:
Inflammation
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Pathologic Processes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases