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NCT01227824 · ClinicalTrials.gov registry record · Phase 3

A Trial Comparing GSK1349572 50mg Once Daily to Raltegravir 400mg Twice Daily

A Phase 3 study, sponsored by ViiV Healthcare.

Completed
Registry status
Phase 3
Development phase
828
Enrollment target

NCT01227824 is a Phase 3 study that has completed, run by ViiV Healthcare. The registered enrollment target is 828 participants.

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The verdict

NCT01227824, a Phase 3 study, has completed, sponsored by ViiV Healthcare.

COMPLETED
Registry status
Phase 3
Development phase
828 participants
Enrollment target

Study Summary

The purpose of this trial is to assess the non-inferior antiviral activity of GSK1349572 50 mg once daily versus RAL 400mg twice daily over 48 weeks; non-inferiority will also be tested at Week 96. Both GSK1349572 and RAL will be given in combination with fixed-dose dual NRTI therapy (ABC/3TC or TDF/FTC). This study will be conducted in HIV-1 infected ART-naïve adult subjects.

Interventions

  • DRUG raltegravir
  • DRUG GSK1349572 (dolutegravir)
  • OTHER GSK1349572 Placebo
  • OTHER ABC/3TC
  • OTHER TDF/FTC

Trial Details

FieldValue
Enrollment Target 828 participants
Start Date 2010-10-19
Est. Completion 2016-12-27
Phase Phase 3

Sponsor

ViiV Healthcare

182 total trials

What the Registry Record Tells You About NCT01227824

The ClinicalTrials.gov registry entry for NCT01227824 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 828 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ViiV Healthcare, which has 182 total studies on file at ClinicalTrials.gov.

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

NCT01227824 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01227824 about?

NCT01227824 is a clinical study titled "A Trial Comparing GSK1349572 50mg Once Daily to Raltegravir 400mg Twice Daily". The purpose of this trial is to assess the non-inferior antiviral activity of GSK1349572 50 mg once daily versus RAL 400mg twice daily over 48 weeks; non-inferiority will also be tested at Week 96. Both GSK1349572 and RAL will be given in combination with fixed-dose dual NRTI therapy (ABC/3TC or TDF...

What is the current status of trial NCT01227824?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 828 participants. The study started on 2010-10-19. Estimated completion is 2016-12-27.

What interventions are being tested in trial NCT01227824?

The interventions under investigation include: raltegravir (DRUG), GSK1349572 (dolutegravir) (DRUG), GSK1349572 Placebo (OTHER), ABC/3TC (OTHER), TDF/FTC (OTHER).

Who is sponsoring clinical trial NCT01227824?

This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.

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

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.