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PrEP Adherence MonitoringPhase 1/2DOT-DBSNCT02022657

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

A Phase 1/2 study testing Truvada in people with PrEP Adherence Monitoring, run by University of Colorado, Denver at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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®). Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
PrEP Adherence Monitoring
What is being tested?
Truvada
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
2 sitesUnited States
Study dates
Apr 2014to Jan 2017
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • Inability to give informed consent
  • A minimum scalp hair length of 2 cm in the occipital region.
  • Pregnancy or plan to become pregnant or unwillingness to use birth control
  • Current breastfeeding.
  • 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)
  • 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)
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  • Positive Hepatitis B (HBV) surface antigen test at screening
  • Active psychiatric illness, social condition, or alcohol/drug abuse that, in the opinion of the investigators, would interfere with study requirements.
  • History of non-traumatic, pathologic bone fractures
  • Glomerular Filtration Rate (GFR, creatinine clearance) < 60 ml/min (MDRD equation).
  • Urine dipstick protein ≥ 2+
  • Total bilirubin and/or hepatic transaminases (ALT and AST) ≥ 2.5x upper limit of normal
  • Absolute neutrophil count ≤ 1,500/mm3, platelets count ≤ 100,000/mm3, or hemoglobin ≤ 10 g/dL.
  • Medical condition that alters red blood cell kinetics including hemoglobinopathies or active hemolysis.
  • Any laboratory value or uncontrolled medical conditions that would interfere with the study conditions such as, heart disease and/or cancer.
  • 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).

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Colorado Denver

    Aurora, Colorado, 80045

  • University of California San Francisco/San Francisco Department of Public Health

    San Francisco, California, 94102

Other trials in United States

About this study

Official title: 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.

Being tested
Truvada
Keywords
Pre exposure prophylaxis, Dried blood spots

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TruvadaDrug

    Also called Tenofovir, Emtricitabine

    Truvada is a combination pill consisting of tenofovir and emtricitabine used in PrEP

Study groups in NCT02022657
Study groupRoleWhat they receive
33%/67%Active comparatorParticipants will be randomized to one of 6 sequences consisting of two directly observed dosing regimens expressed as % of daily dosing of Truvada
Receives: Drug: Truvada
33%/100%Active comparatorParticipants will be randomized to one of 6 sequences consisting of two directly observed dosing regimens expressed as % of daily dosing of Truvada
Receives: Drug: Truvada
67%/33%Active comparatorParticipants will be randomized to one of 6 sequences consisting of two directly observed dosing regimens expressed as % of daily dosing of Truvada
Receives: Drug: Truvada
67%/100%Active comparatorParticipants will be randomized to one of 6 sequences consisting of two directly observed dosing regimens expressed as % of daily dosing of Truvada
Receives: Drug: Truvada
100%/33%Active comparatorParticipants will be randomized to one of 6 sequences consisting of two directly observed dosing regimens expressed as % of daily dosing of Truvada
Receives: Drug: Truvada
100%/67%Active comparatorParticipants will be randomized to one of 6 sequences consisting of two directly observed dosing regimens expressed as % of daily dosing of Truvada
Receives: Drug: Truvada

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Steady State Concentrations of TFV-DP for Different Dosing Patterns of Truvada

    TFV-DP concentrations in DBS respective to dosing regimens of 33%, 67%, 100% of daily dosing.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2013 (estimated)
  2. Study startApr 2014
  3. Primary completionNov 2016
  4. Study completionJan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02022657
Sponsor's protocol ID
13-0427
Other IDs
U01AI106499
Acronym
DOT-DBS
Status last verified
Apr 2019
First submitted
9 Dec 2013
Last updated
30 Apr 2019
Data monitoring committee
Yes
Individual data sharing
No: No plan to share IPD

Publications

  • Anderson PL, Liu AY, Castillo-Mancilla JR, Gardner EM, Seifert SM, McHugh C, Wagner T, Campbell K, Morrow M, Ibrahim M, Buchbinder S, Bushman LR, Kiser JJ, MaWhinney S. Intracellular Tenofovir-Diphosphate and Emtricitabine-Triphosphate in Dried Blood Spots following Directly Observed Therapy. Antimicrob Agents Chemother. 2017 Dec 21;62(1):e01710-17. doi: 10.1128/AAC.01710-17. Print 2018 Jan.

    PubMed 29038282

  • Ibrahim ME, Castillo-Mancilla JR, Yager J, Brooks KM, Bushman L, Saba L, Kiser JJ, MaWhinney S, Anderson PL. Individualized Adherence Benchmarks for HIV Pre-Exposure Prophylaxis. AIDS Res Hum Retroviruses. 2021 Jun;37(6):421-428. doi: 10.1089/AID.2020.0108. Epub 2020 Dec 10.

    PubMed 33191774

  • Grant RM, Pellegrini M, Defechereux PA, Anderson PL, Yu M, Glidden DV, O'Neal J, Yager J, Bhasin S, Sevelius J, Deutsch MB. Sex Hormone Therapy and Tenofovir Diphosphate Concentration in Dried Blood Spots: Primary Results of the Interactions Between Antiretrovirals And Transgender Hormones Study. Clin Infect Dis. 2021 Oct 5;73(7):e2117-e2123. doi: 10.1093/cid/ciaa1160.

    PubMed 32766890

  • Koss CA, Liu AY, Castillo-Mancilla J, Bacchetti P, McHugh C, Kuncze K, Morrow M, Louie A, Seifert S, Okochi H, MaWhinney S, Gandhi M, Anderson PL. Similar tenofovir hair concentrations in men and women after directly observed dosing of tenofovir disoproxil fumarate/emtricitabine: implications for preexposure prophylaxis adherence monitoring. AIDS. 2018 Sep 24;32(15):2189-2194. doi: 10.1097/QAD.0000000000001935.

    PubMed 30212404

  • 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.

    PubMed 27572401

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Truvada in people with PrEP Adherence Monitoring, run by University of Colorado, Denver at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02022657, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2019; AzTrials last refreshed its copy on 6 Nov 2026.

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