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NCT03202511 · ClinicalTrials.gov registry record · Early Phase 1

Assessment of a New "Boosting" Strategy for HIV Pre-exposure Prophylaxis in Healthy Volunteers

A Early Phase 1 study of Pre-exposure Prophylaxis, sponsored by Indiana University.

Completed
Registry status
Early Phase 1
Development phase
15
Enrollment target
1
Study location

NCT03202511 is a Early Phase 1 study of Pre-exposure Prophylaxis that has completed, run by Indiana University. The registered enrollment target is 15 participants, below the 192-participant average among 12 other Pre-exposure Prophylaxis trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03202511, a Early Phase 1 study of Pre-exposure Prophylaxis, has completed, sponsored by Indiana University.

COMPLETED
Registry status
Early Phase 1
Development phase
15 participants
Enrollment target
1
Study location

Study Summary

The study will be a randomized, open-label, cross-over clinical pharmacokinetic trial to investigate a strategy for probenecid "boosting" in the setting of tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) for HIV pre-exposure prophylaxis (PrEP). The study will be conducted at the Indiana University Clinical Research Center. All samples will be processed and the amount of tenofovir/FTC in plasma, blood, and urine, and tenofovir diphosphate and emtricitabine in peripheral blood mononuclear cells will be determined using validated analytical methods developed by the investigators at the University of Colorado. Probenecid plasma and urine concentrations will also be measured using an in-house assay. Following completion of the study, the secondary aim will be accomplished via analysis of selected samples collected at baseline and following treatment. Those selected samples will be assessed for urinary markers of proximal tubulopathy (urine total protein, albumin, creatinine, phosphorus, retinol binding protein, and beta-2-microglobulin) and serum alkaline phosphatase, osteocalcin, procollagen type 1 N propeptide, cystatin C, and creatinine to determine if the probenecid boosting strategy does indeed lead to less potential renal and bone toxicity.

Conditions Studied

Pre-exposure Prophylaxis

Interventions

  • DRUG Probenecid Oral Tablet
  • DRUG Tenofovir disoproxil fumarate/Emtricitabine

Study Locations (1)

Indiana

  • Indiana University Clinical Research Center at University Hospital - Indianapolis

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2017-06-23
Est. Completion 2018-07-02
Phase Early Phase 1

Sponsor

Indiana University

890 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03202511

The ClinicalTrials.gov registry entry for NCT03202511 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 192-participant average among 12 other Pre-exposure Prophylaxis trials with a reported enrollment target (92% lower). The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Pre-exposure Prophylaxis appearing as the primary indexed condition, and to 2 interventions - of which Probenecid Oral Tablet is the first listed.

NCT03202511 reports 1 study location spanning 1 distinct geographic area - top geographies include Indiana.

Frequently Asked Questions

What is clinical trial NCT03202511 about?

NCT03202511 is a clinical study titled "Assessment of a New "Boosting" Strategy for HIV Pre-exposure Prophylaxis in Healthy Volunteers". The study will be a randomized, open-label, cross-over clinical pharmacokinetic trial to investigate a strategy for probenecid "boosting" in the setting of tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) for HIV pre-exposure prophylaxis (PrEP). The study will be conducted at the Indiana Univ...

What is the current status of trial NCT03202511?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 15 participants. The study started on 2017-06-23. Estimated completion is 2018-07-02.

What conditions does trial NCT03202511 study?

This clinical trial studies the following conditions: Pre-exposure Prophylaxis.

What interventions are being tested in trial NCT03202511?

The interventions under investigation include: Probenecid Oral Tablet (DRUG), Tenofovir disoproxil fumarate/Emtricitabine (DRUG).

Who is sponsoring clinical trial NCT03202511?

This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03202511 being conducted?

This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.