MedTrace Logo

Tenofovir Levels Following Local Application of Tenofovir Reduced-Glycerin 1% Gel

NCT01768962 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2021-06-28

No results posted yet for this study

Summary

To compare local and systemic pharmacokinetics of tenofovir reduced-glycerin (TFV RG) 1% gel after 2 weeks of daily rectal use and after 2 weeks of daily vaginal use

Conditions

  • HIV Prevention

Interventions

DRUG

Once Daily Application of TFV RG 1% Gel - Vaginal

Vaginal application

DRUG

Once Daily Application of TFV RG 1% gel - Rectal

Rectal application

DRUG

Once Daily Application of TFV RG 1% gel - Rectal

Rectal application

DRUG

Once Daily Application of TFV RG 1% Gel - Vaginal

Vaginal application

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • CONRAD

    lead OTHER

Principal Investigators

  • Gonasagrie Nair, MBChB · Centre for the AIDS Programme of Research in South Africa (CAPRISA) - eThekwini CRS

  • Jessica Justman, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT01768962 on ClinicalTrials.gov