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



Status:Recruiting
Healthy:No
Age Range:18 - 50
Updated:6/16/2016
Start Date:April 2014
End Date:October 2016
Contact:Sharon Seifert, PharmD
Email:sharon.seifert@ucdenver.edu
Phone:303-724-1087

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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.


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).
We found this trial at
2
sites
1600 Holloway Avenue
San Francisco, California 94102
Principal Investigator: Albert Liu, MD, MPH
Phone: 415-437-7408
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13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
Principal Investigator: Peter L Anderson, PharmD
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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