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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: Clinical Trial Phase 2 study, sponsored by ViiV Healthcare.
NCT01199731 is a Phase 2 study that was terminated before completion, run by ViiV Healthcare. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Plasma for quantitative HIV-1 RNA was collected. The percentage of participants with HIV-1 RNA \<50 copies/mL at Week 16 has been presented. A 2 ml plasma was assayed with the real-time NucliSens EasyQ HIV-1 assay (bioMerieux) capable of quantifying as low as 2.5 c/mL by using three modifications to the standard assay: 15 microliters (µl) of extracted eluate, 20 µl of primer, and 5 µl of 2X enzyme in place of standard kit volumes. The validated assay incorporated molecular beacons for detection.
Interventions
- DRUG Etravirine
- DRUG GSK2248761 100 mg once daily
- DRUG GSK2248761 200 mg once daily
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2010-10-05 |
| Est. Completion | 2011-07-19 |
| Phase | Phase 2 |
Why NCT01199731 stopped before completion
NCT01199731 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 3 interventions - of which Etravirine is the first listed.
NCT01199731 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01199731's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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