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NCT02401230 · ClinicalTrials.gov registry record · Phase 4

PrEP, Lube, and the Rectal Mucosa in MSM at Risk of HIV

A Phase 4 study, sponsored by Emory University.

Completed
Registry status
Phase 4
Development phase
86
Enrollment target

NCT02401230: Completed Phase 4 study, sponsored by Emory University.

NCT02401230 is a Phase 4 study that has completed, run by Emory University. The registered enrollment target is 86 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02401230, a Phase 4 study, has completed, sponsored by Emory University.

COMPLETED
Registry status
Phase 4
Development phase
86 participants
Enrollment target

Study Summary

The purpose of this study is to determine whether the use of rectal lubricants can affect how well the medication, Truvada, will work to prevent infection with HIV when someone is exposed to HIV in the rectum.

Primary Outcome

HIV target cell availability will be assessed by the median percentage of CD4+ T cells that express HIV co-receptor CCR5 as measured prior to product use and on day 8 after product use.

Interventions

  • DRUG Truvada
  • DEVICE Gel lubricant

Trial Details

FieldValue
Enrollment Target 86 participants
Start Date 2015-03
Est. Completion 2017-01-25
Phase Phase 4
Emory University

1,208 total trials

What the finished NCT02401230 record still lists

NCT02401230 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower).

The record links to 0 conditions, and to 2 interventions - of which Truvada is the first listed.

NCT02401230 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02401230 about?

NCT02401230 is a clinical study titled "PrEP, Lube, and the Rectal Mucosa in MSM at Risk of HIV". The purpose of this study is to determine whether the use of rectal lubricants can affect how well the medication, Truvada, will work to prevent infection with HIV when someone is exposed to HIV in the rectum.

What is the current status of trial NCT02401230?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 86 participants. The study started on 2015-03. Estimated completion is 2017-01-25.

What interventions are being tested in trial NCT02401230?

The interventions under investigation include: Truvada (DRUG), Gel lubricant (DEVICE).

Who is sponsoring clinical trial NCT02401230?

This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02401230's enrollment target sits among peer trials

86 926th of 2000 higher than 1,073 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02401230, the US trial registry maintained by the National Library of Medicine. NCT02401230 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.