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

NCT02401230 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2018-02-19

Study results available
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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.

Conditions

Interventions

DRUG

Truvada

Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.

DEVICE

Gel lubricant

Five ml of an over the counter sexual lubricant will be dispensed using an applicator.

Sponsors & Collaborators

Principal Investigators

  • Colleen Kelley, MD/MPH · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2017-01-25
Completion
2017-01-25
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02401230 on ClinicalTrials.gov