Impact of ART Adherence on HIV Persistence and Inflammation

Human Immunodeficiency Virus Clinical Trial

Official title:

Impact of ART Adherence on HIV Persistence and Inflammation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02797093
• Other study ID #: 15-2309
• Secondary ID: 1R21AI124859-01
• Status: Completed
• Start date: January 2016
• Est. completion date: October 12, 2018

Study information

• Verified date: March 2022
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: October 12, 2018
• Est. primary completion date: October 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Inflammation

Locations

Country	Name	City	State
United States	University of Colorado, Denver	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	6 months
Secondary	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.	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.	6 months