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NCT01533259 · ClinicalTrials.gov registry record · Phase 3

Open-Label Pilot Study to Evaluate Switching From a Regimen Consisting of Raltegravir Plus Emtricitabine/Tenofovir DF Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients

A Phase 3 study, sponsored by Gilead Sciences.

Completed
Registry status
Phase 3
Development phase
48
Enrollment target

NCT01533259 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 48 participants.

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The verdict

NCT01533259, a Phase 3 study, has completed, sponsored by Gilead Sciences.

COMPLETED
Registry status
Phase 3
Development phase
48 participants
Enrollment target

Study Summary

This study will evaluate the efficacy of Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF)) single-tablet regimen (STR) after switching from a regimen consisting of raltegravir plus Truvada® (FTC/TDF) at baseline in maintaining HIV-1 RNA \< 50 copies/mL at Week 12 in virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety, tolerability, and efficacy of Stribild over 24 and 48 weeks of treatment.

Interventions

  • DRUG Stribild

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2012-01
Est. Completion 2013-07
Phase Phase 3

Sponsor

Gilead Sciences

504 total trials

What the Registry Record Tells You About NCT01533259

The ClinicalTrials.gov registry entry for NCT01533259 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.

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

NCT01533259 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01533259 about?

NCT01533259 is a clinical study titled "Open-Label Pilot Study to Evaluate Switching From a Regimen Consisting of Raltegravir Plus Emtricitabine/Tenofovir DF Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients". This study will evaluate the efficacy of Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF)) single-tablet regimen (STR) after switching from a regimen consisting of raltegravir plus Truvada® (FTC/TDF) at baseline in maintaining HIV-1 RNA \< 50 copies/m...

What is the current status of trial NCT01533259?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 48 participants. The study started on 2012-01. Estimated completion is 2013-07.

What interventions are being tested in trial NCT01533259?

The interventions under investigation include: Stribild (DRUG).

Who is sponsoring clinical trial NCT01533259?

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

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.