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NCT01276600 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by HIV Prevention Trials Network.

Completed
Registry status
Phase 1
Development phase
32
Enrollment target

NCT01276600: Completed Phase 1 study, sponsored by HIV Prevention Trials Network.

NCT01276600 is a Phase 1 study that has completed, run by HIV Prevention Trials Network. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01276600, a Phase 1 study, has completed, sponsored by HIV Prevention Trials Network.

COMPLETED
Registry status
Phase 1
Development phase
32 participants
Enrollment target

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.

Primary Outcome

Assess dose-proportionality of intracellular TFV-DP and FTC-TP from weekly to daily dosing (Arms 1-4).

Interventions

  • DRUG Emtricitabine/tenofovir

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2011-01
Est. Completion 2011-10
Phase Phase 1
HIV Prevention Trials Network

10 total trials

What the finished NCT01276600 record still lists

NCT01276600 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).

The record links to 0 conditions, and to 1 intervention - of which Emtricitabine/tenofovir is the first listed.

NCT01276600 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01276600 about?

NCT01276600 is a clinical study titled "Dose-Proportionality and Intra-Individual Variability of Intracellular TFV-DP and FTC-TP in Healthy Volunteers". 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.

What is the current status of trial NCT01276600?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2011-01. Estimated completion is 2011-10.

What interventions are being tested in trial NCT01276600?

The interventions under investigation include: Emtricitabine/tenofovir (DRUG).

Who is sponsoring clinical trial NCT01276600?

This trial is sponsored by HIV Prevention Trials Network, which has 10 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01276600's enrollment target sits among peer trials

32 1296th of 2000 higher than 679 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01276600, the US trial registry maintained by the National Library of Medicine. NCT01276600 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.