Trial record 13 of 110 for:    Open Studies | "Exanthema"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Colorado, Denver
Sponsor:
Collaborators:
San Francisco Department of Public Health
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT02022657
First received: December 9, 2013
Last updated: May 16, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
PrEP Adherence Monitoring
Drug: Truvada
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: PrEP Adherence Monitoring Using Dried Blood Spots

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • TFV-DP pharmacokinetics 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. ] [ Designated as safety issue: No ]
    Define the mean, variance, and dose proportionality for TFV-DP in DBS for 33%, 67%, 100% of daily dosing.

  • Establish a model to predict adherence rate by TFV-DP in DBS [ Time Frame: After completion of the study ] [ Designated as safety issue: No ]
    Using the DBS data from the participants assigned to 33%, 67%, or 100% dosing regimen, construct a mathematical model that can be used to assess adherence based on drug levels found in DBS sample.


Secondary Outcome Measures:
  • "intermittent" versus "holiday" pattern of dosing [ Time Frame: Assessed during the dosing periods (every 2 weeks) and at steady-state (weeks 12 and 36). ] [ Designated as safety issue: No ]
    Drug levels will be evaluated to predict the intermittent or holiday pattern of dosing.

  • Describe tenofovir and emtricitabine pharmacokinetics [ Time Frame: Assessed every 2 weeks on the first dosing period, then every 3 weeks during the washout, then every 2 weeks during the second dosing period. ] [ Designated as safety issue: No ]
    Concentrations of drug and relationships will be examined in plasma, Red Blood Cells (RBC), peripheral blood monocyte (PBMC), and hair. Covariates that predict concentrations and relationships will be evaluated.

  • Fingerstick DBS versus DBS from venipuncture [ Time Frame: Assessed at weeks 2, 12, and 28. ] [ Designated as safety issue: No ]
    Paired DBS collected by fingerstick and venipuncture will be compared.

  • Interpret DBS concentrations from PrEP demonstration projects [ Time Frame: after study completion ] [ Designated as safety issue: No ]
    The model described under primary outcome 2 will be used to interpret DBS concentrations collected in PrEP demonstration projects.


Estimated Enrollment: 48
Study Start Date: April 2014
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02022657

Contacts
Contact: Sharon Seifert, PharmD 303-724-1087 sharon.seifert@ucdenver.edu

Locations
United States, California
University of California San Francisco/San Francisco Department of Public Health Recruiting
San Francisco, California, United States, 94102
Contact: Albert Liu, MD, MPH    415-437-7408    albert.liu@sfdph.org   
Principal Investigator: Albert Liu, MD, MPH         
United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Principal Investigator: Peter L Anderson, PharmD         
Sub-Investigator: Jose Castillo-Mancilla, MD         
Sub-Investigator: Edward Gardner, MD         
Sub-Investigator: Samantha MaWhinney, ScD         
Sponsors and Collaborators
University of Colorado, Denver
San Francisco Department of Public Health
Investigators
Principal Investigator: Peter L Anderson, PharmD University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02022657     History of Changes
Other Study ID Numbers: 13-0427, U01AI106499
Study First Received: December 9, 2013
Last Updated: May 16, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
Pre exposure prophylaxis
Dried blood spots

Additional relevant MeSH terms:
Tenofovir
Emtricitabine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on July 28, 2014