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NCT03784079 · ClinicalTrials.gov registry record · Phase 2
A Proof of Concept Study of GSK3640254 in Human Immunodeficiency Virus-1 (HIV-1) Infected Treatment-naive Adults
A Phase 2 study, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
NCT03784079: Completed Phase 2 study, sponsored by ViiV Healthcare.
NCT03784079 is a Phase 2 study that has completed, run by ViiV Healthcare. The registered enrollment target is 34 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03784079, a Phase 2 study, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
Study Summary
Infection with HIV-1 continues to be a serious health threat throughout the world. Chronic exposure to combination anti-retroviral therapy identified anti-retroviral associated long-term toxicities. Hence, there is a need to prevent these co-morbidities. GSK3640254 is a next-generation HIV-1 Maturation Inhibitor (MI) which may be effective for HIV-1 infection. This study will evaluate the antiviral effect, safety, tolerability and pharmacokinetics/ pharmacodynamics of GSK3640254 in HIV-1 infected treatment-naive adults. This study will consists of two parts; Part 1 and Part 2. Part 1 will evaluate two active doses of GSK3640254, 200 milligrams (mg) (Cohort 1) and 10 mg (Cohort 2) along with placebo to match GSK3640254 Mesylate salt. Part 2 will evaluate three active doses of GSK3640254. Dose level 1 of GSK3640254 that can provide at least 30 percent of the maximum effect (Cohort 1), dose level 2 of GSK3640254 that can provide at least 75 percent of the maximum effect (Cohort 2) and dose level 3 of GSK3640254 that can provide at least 90 percent of the maximum effect (Cohort 3). These doses are anticipated to be 5 mg, 40 mg and 100 mg respectively, but could be modified based on data obtained in Part 1. Subjects will also receive placebo to match GSK3640254 Mesylate salt in Part 2 of the study. All doses will be administered after a moderate fat meal. This study will consist of Screening period (up to 14 days), Treatment period (Day 1- Day 10), post-dose Follow-up (Day 11- Day 17) and final Follow-up (Day 18-24). A total of approximately 34 subjects will be enrolled, of which, 14 subjects will be randomized in Part 1 and 20 in Part 2 of the study. Six subjects will be enrolled in each of the active dose cohorts and 2 subjects will be enrolled in each of the placebo cohorts.
Primary Outcome
Plasma samples were collected for quantitative analysis of plasma HIV-1 RNA. A HIV-1 RNA polymerase chain reaction (PCR) assay with a lower limit of detection (LLOD) of 50 copies per milliliter was used. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Interventions
- DRUG GSK3640254
- DRUG Placebo matching GSK3640254 Mesylate salt
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2019-01-31 |
| Est. Completion | 2020-02-06 |
| Phase | Phase 2 |
What the finished NCT03784079 record still lists
NCT03784079 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 2 interventions - of which GSK3640254 is the first listed.
NCT03784079 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03784079 about?
NCT03784079 is a clinical study titled "A Proof of Concept Study of GSK3640254 in Human Immunodeficiency Virus-1 (HIV-1) Infected Treatment-naive Adults". Infection with HIV-1 continues to be a serious health threat throughout the world. Chronic exposure to combination anti-retroviral therapy identified anti-retroviral associated long-term toxicities. Hence, there is a need to prevent these co-morbidities. GSK3640254 is a next-generation HIV-1 Maturat...
What is the current status of trial NCT03784079?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2019-01-31. Estimated completion is 2020-02-06.
What interventions are being tested in trial NCT03784079?
The interventions under investigation include: GSK3640254 (DRUG), Placebo matching GSK3640254 Mesylate salt (DRUG).
Who is sponsoring clinical trial NCT03784079?
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 NCT03784079's enrollment target sits among peer trials
34 1539th of 2000 higher than 448 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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