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PK and PD Study of Oral F/TAF for HIV Prevention

NCT02904369 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2018-02-19

No results posted yet for this study

Summary

This multi-center Phase I study is designed to characterize the PK and PD of F/TAF oral tablets to assess systemic and genital tract bioavailability in healthy women. The oral tablets to be used in the study are F/TAF (200/10 mg), F/TAF (200/25 mg) and F/TDF (200/300 mg, Truvada). Samples will be obtained before, during and after dosing in two study phases.

Conditions

Interventions

DRUG

Emtricitabine

DRUG

Tenofovir alafenamide

DRUG

Tenofovir disoproxil

Sponsors & Collaborators

  • United States Agency for International Development (USAID)

    collaborator FED

  • Agility Clinical, Inc.

    collaborator INDUSTRY

  • CONRAD

    lead OTHER

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
2016-10-06
Primary Completion
2017-11-21
Completion
2017-11-21

Countries

  • United States
  • Dominican Republic

Study Locations

More Related Trials

Entities

Drugs
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 NCT02904369 on ClinicalTrials.gov