Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study, sponsored by ViiV Healthcare.
NCT01227824 is a Phase 3 study that has completed, run by ViiV Healthcare. The registered enrollment target is 828 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
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.
Primary Outcome
Percentage of participants with plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) with \<50 c/mL was assessed using the Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) snapshot algorithm. The algorithm treats all participants without HIV-1 RNA data as non-responders, as well as participants who switch their concomitant Antiretroviral Therapy (ART) prior to Week 48 as follows: background ART substitutions not permitted
Interventions
- DRUG raltegravir
- DRUG GSK1349572 (dolutegravir)
- OTHER GSK1349572 Placebo
- OTHER ABC/3TC
- OTHER TDF/FTC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 828 participants |
| Start Date | 2010-10-19 |
| Est. Completion | 2016-12-27 |
| Phase | Phase 3 |
What the finished NCT01227824 record still lists
NCT01227824 is an interventional study that assigns participants to a tested intervention. The registered 828 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 raltegravir is the first listed.
NCT01227824 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01227824's enrollment target sits among peer trials
828 400th of 2000 higher than 1,601 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05124808 · 828 participants · NA
Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes
- NCT03547973 · 827 participants · Phase 2
Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread
- NCT05067283 · 830 participants · Phase 1
A Study of Calderasib (MK-1084) in KRAS Mutant Advanced Solid Tumors (MK-1084-001)
- NCT06592924 · 830 participants · Phase 3
Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI