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Safety, PK, and PD Study of IVRs Releasing TFV and LNG

NCT03279120 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2019-07-23

No results posted yet for this study

Summary

This multi-center Phase I study is designed to characterize the safety, PK, and PD of TFV/LNG IVR to assess systemic and genital tract bioavailability in healthy women. The IVRs to be used in the study are TFV/LNG IVR (8-10mg per day/20μg per day) or placebo IVR. Samples will be obtained before, during and after 90 days of continuous or interrupted IVR use.

Conditions

  • Anti-Infective Agents
  • Anti-Retroviral Agents
  • Contraceptive Usage

Interventions

DRUG

TFV/LNG IVR

Used for 90 days (Continuous or Interrupted)

DRUG

Placebo

Used for 90 days (Continuous or Interrupted)

Sponsors & Collaborators

  • United States Agency for International Development (USAID)

    collaborator FED

  • Agility Clinical, Inc.

    collaborator INDUSTRY

  • CONRAD

    lead OTHER

Principal Investigators

  • study director · CONRAD

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-09-28
Primary Completion
2018-12-26
Completion
2018-12-26
FDA Drug
Yes

Countries

  • United States
  • Dominican Republic

Study Locations

More Related Trials

Entities

Drugs

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 NCT03279120 on ClinicalTrials.gov