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NCT01199731 · ClinicalTrials.gov registry record · Phase 2

Dose-finding Study of GSK2248761 in Antiretroviral Therapy-experienced Subjects With NNRTI-resistant HIV Infection

A Phase 2 study, sponsored by ViiV Healthcare.

Terminated
Registry status
Phase 2
Development phase
30
Enrollment target

NCT01199731 is a Phase 2 study that was terminated before completion, run by ViiV Healthcare. The registered enrollment target is 30 participants.

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The verdict

NCT01199731, a Phase 2 study, was terminated before completion, sponsored by ViiV Healthcare.

TERMINATED
Registry status
Phase 2
Development phase
30 participants
Enrollment target

Study Summary

This 48 week, phase 2b study in 150 HIV-1 infected antiretroviral therapy experienced adult subjects consists of a dose-ranging evaluation of GSK2248761 at blinded doses of 100 mg and 200 mg once daily with a control arm of open-label etravirine (ETV) 200 mg twice daily. The background ART for all three arms will be darunavir/ritonavir (DRV/r) 600 mg/100 mg twice daily plus raltegravir (RAL) 400 mg twice daily. Antiviral activity, safety, PK, and development of viral resistance will be evaluated.

Interventions

  • DRUG Etravirine
  • DRUG GSK2248761 100 mg once daily
  • DRUG GSK2248761 200 mg once daily

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2010-10-05
Est. Completion 2011-07-19
Phase Phase 2

Sponsor

ViiV Healthcare

182 total trials

What the Registry Record Tells You About NCT01199731

The ClinicalTrials.gov registry entry for NCT01199731 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 30 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 3 interventions - of which Etravirine is the first listed.

NCT01199731 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01199731 about?

NCT01199731 is a clinical study titled "Dose-finding Study of GSK2248761 in Antiretroviral Therapy-experienced Subjects With NNRTI-resistant HIV Infection". This 48 week, phase 2b study in 150 HIV-1 infected antiretroviral therapy experienced adult subjects consists of a dose-ranging evaluation of GSK2248761 at blinded doses of 100 mg and 200 mg once daily with a control arm of open-label etravirine (ETV) 200 mg twice daily. The background ART for all t...

What is the current status of trial NCT01199731?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2010-10-05. Estimated completion is 2011-07-19.

What interventions are being tested in trial NCT01199731?

The interventions under investigation include: Etravirine (DRUG), GSK2248761 100 mg once daily (DRUG), GSK2248761 200 mg once daily (DRUG).

Who is sponsoring clinical trial NCT01199731?

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.