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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: Completed Phase 3 study, sponsored by ViiV Healthcare.
NCT01231516 is a Phase 3 study that has completed, run by ViiV Healthcare. The registered enrollment target is 724 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.
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.
Primary Outcome
The percentage of participants with Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) \<50 c/mL at Week 48 was assessed using the Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) "snapshot" algorithm. This algorithm treated all participants without HIV-1 RNA at Week 48 as nonresponders, as well as participants who switched their concomitant ART prior to Week 48 as follows: background ART substitutions non-permitted per
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 |
What the finished NCT01231516 record still lists
NCT01231516 is an interventional study that assigns participants to a tested intervention. The registered 724 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 4 interventions - of which Raltegravir is the first listed.
NCT01231516 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01231516's enrollment target sits among peer trials
724 491st of 2000 higher than 1,509 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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