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NCT04493216 · ClinicalTrials.gov registry record · Phase 2
A Dose-Range Finding Clinical Trial Study in Human Immunodeficiency Virus (HIV-1) Infected Treatment-Naive Adults
A Phase 2 study, sponsored by ViiV Healthcare.
- Terminated
- Registry status
- Phase 2
- Development phase
- 161
- Enrollment target
NCT04493216: Clinical Trial Phase 2 study, sponsored by ViiV Healthcare.
NCT04493216 is a Phase 2 study that was terminated before completion, run by ViiV Healthcare. The registered enrollment target is 161 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (21% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04493216, a Phase 2 study, was terminated before completion, sponsored by ViiV Healthcare.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 161 participants
- Enrollment target
Study Summary
This is a phase 2b, randomized, multicenter, parallel group, partially blind (to GSK3640254 doses \[100, 150 and 200 milligrams {mg}\]), active controlled clinical trial. It aims to investigate the safety, efficacy and dose-response of GSK3640254 compared to dolutegravir (DTG), each given in combination with 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs) (abacavir/lamivudine \[ABC/3TC\] or emtricitabine/tenofovir alafenamide \[FTC/TAF\]).
Primary Outcome
Percentage of participants with plasma HIV-1 RNA \<50 c/mL at week 24 was assessed using the Food and Drug Administration (FDA) snapshot algorithm to demonstrate the antiviral activity of GSK3640254 given in combination with either ABC/3TC or FTC/TAF compared to the reference treatment of DTG given in combination with either ABC/3TC or FTC/TAF.
Interventions
- DRUG Placebo
- DRUG Dolutegravir
- DRUG FTC/TAF
- DRUG GSK3640254
- DRUG ABC/3TC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 161 participants |
| Start Date | 2020-11-18 |
| Est. Completion | 2023-05-29 |
| Phase | Phase 2 |
Why NCT04493216 stopped before completion
NCT04493216 is an interventional study that assigns participants to a tested intervention. The registered 161 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (21% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT04493216 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04493216 about?
NCT04493216 is a clinical study titled "A Dose-Range Finding Clinical Trial Study in Human Immunodeficiency Virus (HIV-1) Infected Treatment-Naive Adults". This is a phase 2b, randomized, multicenter, parallel group, partially blind (to GSK3640254 doses \[100, 150 and 200 milligrams {mg}\]), active controlled clinical trial. It aims to investigate the safety, efficacy and dose-response of GSK3640254 compared to dolutegravir (DTG), each given in combina...
What is the current status of trial NCT04493216?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 161 participants. The study started on 2020-11-18. Estimated completion is 2023-05-29.
What interventions are being tested in trial NCT04493216?
The interventions under investigation include: Placebo (DRUG), Dolutegravir (DRUG), FTC/TAF (DRUG), GSK3640254 (DRUG), ABC/3TC (DRUG).
Who is sponsoring clinical trial NCT04493216?
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 NCT04493216's enrollment target sits among peer trials
161 422nd of 2000 higher than 1,579 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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