Impact of ART Adherence on HIV Persistence and Inflammation

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02797093

Enrollment

Registered

2016-06-13

Start date

2016-01-31

Completion date

2018-10-12

Last updated

2022-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Immunodeficiency Virus

Keywords

anti-retroviral therapy

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.

Interventions

None listed

Study design

Observational model

ECOLOGIC_OR_COMMUNITY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.	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

Measure	Time frame	Description
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.	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.

Countries

United States

Outcome results