Pre-Exposure Prophylaxis (PrEP) Adherence Monitoring Using Dried Blood Spots (DOT-DBS)

April 19, 2019 updated by: University of Colorado, Denver

PrEP Adherence Monitoring Using Dried Blood Spots

The primary objective of this study is to define the mean, variance, and dose proportionality for tenofovir-diphosphate(TFV-DP) in dried blood spots resulting from 33%, 67%, and 100% of daily dosing with 200mg emtricitabine and 300mg of tenofovir disoproxil fumarate (as Truvada®). With this information, a model will be established to predict adherence rates to TFV-DP using DBS. Forty-eight healthy HIV-uninfected adult participants who are at low risk for HIV infection will be randomized to one of 6 sequences consisting of two directly observed dosing regimens, 33%/67%, 33%/100%, 67%/33%, 67%/100%, 100%/33%, and 100%/67% with each dose regimen lasting approximately 12 weeks, separated by an approximately 12 week washout period. DBS will be collected at regular intervals, including during the washout. The hypothesis of the study is that levels of TFV-DP in DBS will predict adherence rates in the preceding 1-3 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94102
        • University of California San Francisco/San Francisco Department of Public Health
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Ambulatory 18-50 year old adults. Enrollment will target approximately half women and approximately one third African-Americans and one third Latino.
  2. Ability to comply with study procedures, including directly observed dosing visits and availability and use of audio-video streaming technology.

Exclusion Criteria:

  1. Inability to give informed consent
  2. A minimum scalp hair length of 2 cm in the occipital region.
  3. Pregnancy or plan to become pregnant or unwillingness to use birth control
  4. Current breastfeeding.
  5. High risk of HIV-1 infection (for example: sexually active with an HIV infected partner; men who have sex with men who may engage in condom-less intercourse with HIV-infected partners or partner of unknown status during the study; males or females who exchange sex for money, shelter, or gifts; active injection drug use or during the last 12 months; newly diagnosed sexually transmitted infections in last 6 months)
  6. Positive screening HIV+ ELISA or suspected acute HIV infection in the opinion of the clinician. (example signs and symptoms of acute HIV infection include combinations of fever, headache, fatigue, arthralgia, vomiting, myalgia, diarrhea, pharyngitis, rash, night sweats, and adenopathy cervical or inguinal)
  7. Positive Hepatitis B (HBV) surface antigen test at screening
  8. Active psychiatric illness, social condition, or alcohol/drug abuse that, in the opinion of the investigators, would interfere with study requirements.
  9. History of non-traumatic, pathologic bone fractures
  10. Glomerular Filtration Rate (GFR, creatinine clearance) < 60 ml/min (MDRD equation).
  11. Urine dipstick protein ≥ 2+
  12. Total bilirubin and/or hepatic transaminases (ALT and AST) ≥ 2.5x upper limit of normal
  13. Absolute neutrophil count ≤ 1,500/mm3, platelets count ≤ 100,000/mm3, or hemoglobin ≤ 10 g/dL.
  14. Medical condition that alters red blood cell kinetics including hemoglobinopathies or active hemolysis.
  15. Any laboratory value or uncontrolled medical conditions that would interfere with the study conditions such as, heart disease and/or cancer.
  16. Contraindicated concomitant medications (including investigational agents, aminoglycosides, ganciclovir/valganciclovir, chronic high-dose acyclovir/valacyclovir, cyclosporine, amphotericin B, foscarnet, and cidofovir, and products with same or similar active ingredients as the study medications (Truvada®) including ATRIPLA®, COMPLERA®, EMTRIVA®, VIREAD®; or drugs containing lamivudine or adefovir, which are close analogs of Emtricitabine (FTC) and tenofovir, respectively).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 33%/67%
Participants will be randomized to one of 6 sequences consisting of two directly observed dosing regimens expressed as % of daily dosing of Truvada
Drug: Truvada
Truvada is a combination pill consisting of tenofovir and emtricitabine used in PrEP
Other Names:
  • Tenofovir
  • Emtricitabine
Active Comparator: 33%/100%
Participants will be randomized to one of 6 sequences consisting of two directly observed dosing regimens expressed as % of daily dosing of Truvada
Drug: Truvada
Truvada is a combination pill consisting of tenofovir and emtricitabine used in PrEP
Other Names:
  • Tenofovir
  • Emtricitabine
Active Comparator: 67%/33%
Participants will be randomized to one of 6 sequences consisting of two directly observed dosing regimens expressed as % of daily dosing of Truvada
Drug: Truvada
Truvada is a combination pill consisting of tenofovir and emtricitabine used in PrEP
Other Names:
  • Tenofovir
  • Emtricitabine
Active Comparator: 67%/100%
Participants will be randomized to one of 6 sequences consisting of two directly observed dosing regimens expressed as % of daily dosing of Truvada
Drug: Truvada
Truvada is a combination pill consisting of tenofovir and emtricitabine used in PrEP
Other Names:
  • Tenofovir
  • Emtricitabine
Active Comparator: 100%/33%
Participants will be randomized to one of 6 sequences consisting of two directly observed dosing regimens expressed as % of daily dosing of Truvada
Drug: Truvada
Truvada is a combination pill consisting of tenofovir and emtricitabine used in PrEP
Other Names:
  • Tenofovir
  • Emtricitabine
Active Comparator: 100%/67%
Participants will be randomized to one of 6 sequences consisting of two directly observed dosing regimens expressed as % of daily dosing of Truvada
Drug: Truvada
Truvada is a combination pill consisting of tenofovir and emtricitabine used in PrEP
Other Names:
  • Tenofovir
  • Emtricitabine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Steady State Concentrations of TFV-DP for Different Dosing Patterns of Truvada
Time Frame: Assessed every 2 weeks during the dosing periods and at steady-state, week 12 for the first dosing period and week 36 for the second dosing period.
TFV-DP concentrations in DBS respective to dosing regimens of 33%, 67%, 100% of daily dosing.
Assessed every 2 weeks during the dosing periods and at steady-state, week 12 for the first dosing period and week 36 for the second dosing period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
San Francisco Department of Public Health

Investigators

  • Principal Investigator: Peter L Anderson, PharmD, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2014

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

December 9, 2013

First Submitted That Met QC Criteria

December 23, 2013

First Posted (Estimate)

December 30, 2013

Study Record Updates

Last Update Posted (Actual)

April 30, 2019

Last Update Submitted That Met QC Criteria

April 19, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-0427
  • U01AI106499 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No plan to share IPD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on PrEP Adherence Monitoring

Clinical Trials on Truvada

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ireland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe