Quantifying Drug Adherence and Drug Exposure to Antiretroviral Therapy

NCT02012621 | Completed Results

• 1 other identifier: 13-2104
• Study Type: observational
• Target: 807
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate cumulative exposure to tenofovir diphosphate (TFV-DP) using dried blood spots (DBS) in treated HIV-infected patients who are receiving a TFV-based regimen. Using DBS will allow the investigators to assess this simple method to measure drug exposure in the clinical setting. The investigators hypothesize that TFV-DP levels will be lowest in individuals with a detectable viral load and highest in those with viral suppression.

Conditions

HIV/AIDS

Keywords

HIV/AIDS; Adherence; Tenofovir; Dried Blood Spots

Outcome Measures

Primary Outcomes (3)

• Adjusted Odds Ratio of Level of Tenofovir-diphosphate (TFV-DP) in Dried Blood Spots (DBS) Associated With Odds of HIV Viral Suppression at All Study Visits

  HIV viral load, binary cutoff at assay level of detection (\<20 copies/mL vs. \>= 20 copies/mL); reference group: drug concentration (TFV-DP) \< 350 femtomole (fmol)/punch vs. drug concentration (TFV-DP) \>= 1850 fmol/punch; adjusted odds ratio calculated using generalized estimating equations; concentration cutoffs established in prior research of healthy volunteers

  Up to 48 Weeks

• Adjusted Odds Ratio of Three-month Self-reported Adeherence Associated With Odds of HIV Viral Suppression at All Study Visits

  HIV viral load, binary cutoff at assay level of detection (\<20 copies/mL vs. \>= 20 copies/mL); reference group: three-month self-reported adherence \<28.5% vs. three-month self-reported adherence 100%; adherence cutoffs established in prior research

  Up to 48 Weeks

• Adjusted Odds Ratio of Level of Tenofovir-diphosphate (TFV-DP) in Dried Blood Spots (DBS) Associated With Odds of HIV Viral Suppression at Next Study Visit

  HIV viral load, binary cutoff at assay level of detection (\<20 copies/mL vs. \>= 20 copies/mL); drug concentration (TFV-DP) \<800 femtomole (fmol)/punch) vs reference group of drug concentration (TFV-DP) \>= 1650 fmol/punch; adjusted odds ratio calculated using generalized estimating equations

  Up to 48 Weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV-infected individuals who are taking tenofovir.

You may qualify if:

• HIV-infected individual.
• years and older.
• Taking tenofovir.
• Blood drawn during regular clinic visit.

You may not qualify if:

• Refusal to participate.
• Pregnancy.
• Inability to provide informed consent.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado-Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Related Publications (3)

• Morrow M, MaWhinney S, Coyle RP, Coleman SS, Gardner EM, Zheng JH, Ellison L, Bushman LR, Kiser JJ, Anderson PL, Castillo-Mancilla JR. Predictive Value of Tenofovir Diphosphate in Dried Blood Spots for Future Viremia in Persons Living With HIV. J Infect Dis. 2019 Jul 19;220(4):635-642. doi: 10.1093/infdis/jiz144.

  PMID: 30942881 DERIVED

• Castillo-Mancilla JR, Morrow M, Coyle RP, Coleman SS, Gardner EM, Zheng JH, Ellison L, Bushman LR, Kiser JJ, Mawhinney S, Anderson PL. Tenofovir Diphosphate in Dried Blood Spots Is Strongly Associated With Viral Suppression in Individuals With Human Immunodeficiency Virus Infections. Clin Infect Dis. 2019 Apr 8;68(8):1335-1342. doi: 10.1093/cid/ciy708.

  PMID: 30137238 DERIVED

• Castillo-Mancilla J, Seifert S, Campbell K, Coleman S, McAllister K, Zheng JH, Gardner EM, Liu A, Glidden DV, Grant R, Hosek S, Wilson CM, Bushman LR, MaWhinney S, Anderson PL. Emtricitabine-Triphosphate in Dried Blood Spots as a Marker of Recent Dosing. Antimicrob Agents Chemother. 2016 Oct 21;60(11):6692-6697. doi: 10.1128/AAC.01017-16. Print 2016 Nov.

  PMID: 27572401 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Dr. Jose Castillo-Mancilla
• Organization: University of Colorado-AMC

jose.castillo-mancilla@cuanschutz.edu

303-724-4934

Study Officials

• Jose R. Castillo-Mancilla, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2013
• First Posted: December 16, 2013
• Study Start: December 1, 2013
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: November 25, 2019
• Results First Posted: November 25, 2019

Record last verified: 2019-10

Locations

US (1)