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NCT01231516 · ClinicalTrials.gov registry record · Phase 3
A Study of GSK1349572 Versus Raltegravir (RAL) With Investigator Selected Background Regimen in Antiretroviral-Experienced, Integrase Inhibitor-Naive Adults
A Phase 3 study, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 3
- Development phase
- 724
- Enrollment target
NCT01231516 is a Phase 3 study that has completed, run by ViiV Healthcare. The registered enrollment target is 724 participants.
The verdict
NCT01231516, a Phase 3 study, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 724 participants
- Enrollment target
Study Summary
ING111762 is a 48 week, randomized, double-blind, active-controlled, multicenter, parallel group, non-inferiority study. The study will be conducted in at least 688 HIV-1 infected antiretroviral experienced, integrase-naïve subjects. Subjects will be randomized 1:1 to receive GSK1349572 50 mg once daily or raltegravir (RAL) 400 mg twice daily, each added to an investigator selected background regimen consisting of at least one fully active agent plus no more than one second single agent which may or may not be active. Antiviral activity, safety, pharmacokinetics (PK), and development of viral resistance will be evaluated.
Interventions
- DRUG Raltegravir
- DRUG GSK1349572
- DRUG GSK1349572 Placebo
- DRUG Raltegravir Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 724 participants |
| Start Date | 2010-10-26 |
| Est. Completion | 2021-02-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01231516
The ClinicalTrials.gov registry entry for NCT01231516 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 724 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 4 interventions - of which Raltegravir is the first listed.
NCT01231516 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01231516 about?
NCT01231516 is a clinical study titled "A Study of GSK1349572 Versus Raltegravir (RAL) With Investigator Selected Background Regimen in Antiretroviral-Experienced, Integrase Inhibitor-Naive Adults". ING111762 is a 48 week, randomized, double-blind, active-controlled, multicenter, parallel group, non-inferiority study. The study will be conducted in at least 688 HIV-1 infected antiretroviral experienced, integrase-naïve subjects. Subjects will be randomized 1:1 to receive GSK1349572 50 mg once d...
What is the current status of trial NCT01231516?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 724 participants. The study started on 2010-10-26. Estimated completion is 2021-02-02.
What interventions are being tested in trial NCT01231516?
The interventions under investigation include: Raltegravir (DRUG), GSK1349572 (DRUG), GSK1349572 Placebo (DRUG), Raltegravir Placebo (DRUG).
Who is sponsoring clinical trial NCT01231516?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
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