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Safety, PK, and PD Study of a Vaginal Insert Containing TAF and EVG

NCT03762772 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2019-07-16

No results posted yet for this study

Summary

The purpose of this Phase I study is to assess the safety, pharmacokinetics, and pharmacodynamics of a combination vaginal insert containing tenofovir alafenamide (TAF) and elvitegravir (EVG).

This study will be the first-in-human study for a vaginally administered TAF/EVG insert and will evaluate safety, PK and PD after a single dose. It is hypothesized that the combination insert will be safe and well-tolerated by study participants and that the insert will offer an expanded window of preventive activity and a regimen with flexibility and forgiveness.

Conditions

Interventions

DRUG

TAF/EVG Vaginal Insert

1 combination vaginal insert (20mg TAF/16mg EVG)

Sponsors & Collaborators

  • Eastern Virginia Medical School

    collaborator OTHER

  • United States Agency for International Development (USAID)

    collaborator FED

  • CONRAD

    lead OTHER

Principal Investigators

  • Medical Director · CONRAD

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-10
Primary Completion
2019-03-20
Completion
2019-03-20
FDA Drug
Yes

Countries

  • United States

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 NCT03762772 on ClinicalTrials.gov