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Safety and Acceptability Study of Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet and Rectally-Applied Tenofovir Reduced-Glycerin 1% Gel

NCT01687218 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 195

Last updated 2021-06-24

Study results available
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Summary

MTN-017 is a Phase 2, multi-site, randomized, six-sequence, two three-period, open label crossover study, examining the effects of oral Truvada and reduced glycerin 1% tenofovir gel. The study population will be sexually active, HIV-uninfected males who are 18 years of age or older, who report a history of receptive anal intercourse in the past 3 months. Each of the study product regimens offers different advantages to participants seeking an effective HIV prevention agent. How these relative advantages will compare in terms of safety, acceptability, systemic and local absorption, and adherence will be examined within this study.

Conditions

Interventions

DRUG

Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)

DRUG

Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)

DRUG

Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • National Institutes of Health (NIH)

    collaborator NIH

  • CONRAD

    lead OTHER

Principal Investigators

  • Ross D. Cranston, MD, FRCP · University of Pittsburgh Medical Center (UPMC)

  • Javier R. Lama, MD, MPH · Asociacion Civil Impacta Salud y Educacion (IMPACTA)

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-25
Primary Completion
2015-05-26
Completion
2015-05-26

Countries

  • United States
  • Peru
  • Puerto Rico
  • South Africa
  • Thailand

Study Locations

More Related Trials

Entities

Diseases

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 NCT01687218 on ClinicalTrials.gov