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Dose-Proportionality and Intra-Individual Variability of Intracellular TFV-DP and FTC-TP in Healthy Volunteers

NCT01276600 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-03-25

No results posted yet for this study

Summary

Describe the dose-proportionality and intra-individual variability of tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP) at steady-state in healthy human participants taking Truvada® (FTC 200mg/TDF 300 mg) under direct observation.

Conditions

Interventions

DRUG

Emtricitabine/tenofovir

200mg of emtricitabine 300mg of tenofovir

Sponsors & Collaborators

  • HIV Prevention Trials Network

    lead NETWORK

Principal Investigators

  • Craig Hendrix, MD · Johns Hopkins University

  • Kristine Patterson, MD · University of North Carolina

  • Kenneth Mayer, MD · Brown University

  • Adriana Andrade, MD, MPH · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-10-31
Completion
2011-10-31

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 NCT01276600 on ClinicalTrials.gov