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CompletedNCT02797093Updated Mar 8, 2022

Impact of ART Adherence on HIV Persistence and Inflammation

An observational study in Human Immunodeficiency Virus, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-08.

Sponsored by University of Colorado, Denver · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Prospective
Enrollment
71
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.
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Conditions studied

  • Human Immunodeficiency Virus

Keywords

  • anti-retroviral therapy
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In context

Acquired Immunodeficiency Syndrome

2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.

This study's enrollment of 71 is below the median of 236 across 355 observational studies indexed under Acquired Immunodeficiency Syndrome.

Browse Acquired Immunodeficiency Syndrome studies →

Lead sponsor

University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.

Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

HIV-infected individuals who are being treated with a tenofovir-based regimen.

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

Exclusion Criteria:

  1. Pregnancy.
  2. Refusal to participate.
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Study design

Observational model
Ecologic or community
Time perspective
Prospective
Enrollment
71 participants (actual)
Target follow-up
6 Months
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • HIV suppressed individuals

    HIV suppressed individuals on chronic ART, suboptimal adherence and exposure, measured through TFV-DP in DBS.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

Secondary outcomes

  1. 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.

    Time frame: 6 months

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Study locations

1 site
  • University of Colorado, Denver
    Aurora, Colorado 80045, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02797093
Lead sponsor
University of Colorado, Denver
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Responsible party
Sponsor
First posted
Jun 13, 2016
Start date
Jan 2016
Primary completion
Oct 12, 2018
Completion
Oct 12, 2018
Last update
Mar 8, 2022

Study contacts

Jose R Castillo-Mancilla, MD
principal investigator · University of Colorado, Denver

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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