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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: Completed Phase 3 study, sponsored by Gilead Sciences.

NCT01106586 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 708 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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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
Gilead Sciences

504 total trials

What the finished NCT01106586 record still lists

NCT01106586 is an interventional study that assigns participants to a tested intervention. The registered 708 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.

The record links to 0 conditions, and to 5 interventions - of which Ritonavir is the first listed.

NCT01106586 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01106586's enrollment target sits among peer trials

708 505th of 2000 higher than 1,496 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 NCT01106586, the US trial registry maintained by the National Library of Medicine. NCT01106586 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.