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NCT01106586 · ClinicalTrials.gov registry record · Phase 3

Study to Evaluate the Safety and Efficacy of Stribild Versus Ritonavir-Boosted Atazanavir Plus Truvada in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

A Phase 3 study, sponsored by Gilead Sciences.

Completed
Registry status
Phase 3
Development phase
708
Enrollment target

NCT01106586 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 708 participants.

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The verdict

NCT01106586, a Phase 3 study, has completed, sponsored by Gilead Sciences.

COMPLETED
Registry status
Phase 3
Development phase
708 participants
Enrollment target

Study Summary

To evaluate the safety and efficacy of Stribild®, a single tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/cobicistat (COBI \[GS-9350\])/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus ritonavir-boosted atazanavir (ATV/r) plus the standard of care nucleoside reverse transcriptase inhibitor (NRTI) backbone FTC/TDF (Truvada®). ATV/r + FTC/TDF was selected as the active comparator for this study as it is a preferred protease inhibitor-based regimen in guidelines for the treatment of HIV-1 infected, antiretroviral treatment-naive adults.

Interventions

  • DRUG Ritonavir
  • DRUG FTC/TDF
  • DRUG ATV
  • DRUG Stribild
  • DRUG Stribild Placebo

Trial Details

FieldValue
Enrollment Target 708 participants
Start Date 2010-04
Est. Completion 2014-09
Phase Phase 3

Sponsor

Gilead Sciences

504 total trials

What the Registry Record Tells You About NCT01106586

The ClinicalTrials.gov registry entry for NCT01106586 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 708 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 5 interventions - of which Ritonavir is the first listed.

NCT01106586 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01106586 about?

NCT01106586 is a clinical study titled "Study to Evaluate the Safety and Efficacy of Stribild Versus Ritonavir-Boosted Atazanavir Plus Truvada in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults". To evaluate the safety and efficacy of Stribild®, a single tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/cobicistat (COBI \[GS-9350\])/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus ritonavir-boosted atazanavir (ATV/r) plus the standard of care nucleoside reverse ...

What is the current status of trial NCT01106586?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 708 participants. The study started on 2010-04. Estimated completion is 2014-09.

What interventions are being tested in trial NCT01106586?

The interventions under investigation include: Ritonavir (DRUG), FTC/TDF (DRUG), ATV (DRUG), Stribild (DRUG), Stribild Placebo (DRUG).

Who is sponsoring clinical trial NCT01106586?

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.