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NCT01818596 · ClinicalTrials.gov registry record · Phase 3

Open-label Safety Study of E/C/F/TAF (Genvoya®) in HIV-1 Positive Patients With Mild to Moderate Renal Impairment

A Phase 3 study, sponsored by Gilead Sciences.

Completed
Registry status
Phase 3
Development phase
252
Enrollment target

NCT01818596: Completed Phase 3 study, sponsored by Gilead Sciences.

NCT01818596 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 252 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01818596, a Phase 3 study, has completed, sponsored by Gilead Sciences.

COMPLETED
Registry status
Phase 3
Development phase
252 participants
Enrollment target

Study Summary

The primary objective of this study is to evaluate the effect of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) tablet on renal parameters at Week 24 in treatment-naive and treatment-experienced HIV-positive, adults with mild to moderate renal impairment.

Primary Outcome

eGFR is a measurement of the kidney's ability to filter blood.

Interventions

  • DRUG E/C/F/TAF

Trial Details

FieldValue
Enrollment Target 252 participants
Start Date 2013-03-27
Est. Completion 2018-07-18
Phase Phase 3
Gilead Sciences

504 total trials

What the finished NCT01818596 record still lists

NCT01818596 is an interventional study that assigns participants to a tested intervention. The registered 252 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (67% lower).

The record links to 0 conditions, and to 1 intervention - of which E/C/F/TAF is the first listed.

NCT01818596 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01818596 about?

NCT01818596 is a clinical study titled "Open-label Safety Study of E/C/F/TAF (Genvoya®) in HIV-1 Positive Patients With Mild to Moderate Renal Impairment". The primary objective of this study is to evaluate the effect of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) tablet on renal parameters at Week 24 in treatment-naive and treatment-experienced HIV-positive, adults with mild to moderate renal im...

What is the current status of trial NCT01818596?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 252 participants. The study started on 2013-03-27. Estimated completion is 2018-07-18.

What interventions are being tested in trial NCT01818596?

The interventions under investigation include: E/C/F/TAF (DRUG).

Who is sponsoring clinical trial NCT01818596?

This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01818596's enrollment target sits among peer trials

252 1246th of 2000 higher than 752 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT01818596, the US trial registry maintained by the National Library of Medicine. NCT01818596 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.