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NCT04811040 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Safety and Efficacy of Teropavimab and Zinlirvimab in Combination With Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection
A Phase 1 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT04811040: Completed Phase 1 study, sponsored by Gilead Sciences.
NCT04811040 is a Phase 1 study that has completed, run by Gilead Sciences. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04811040, a Phase 1 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the safety and tolerability of a combination of the broadly neutralizing antibodies (bNAbs) teropavimab (formerly GS-5423) and zinlirvimab (formerly GS-2872) in combination with the HIV capsid inhibitor lenacapavir (LEN).
Primary Outcome
A treatment emergent SAE was defined as an event that, at any dose, resulted in the following: death; life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; a congenital anomaly/birth defect; a medically important event or reaction: such events may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent one of the ot
Interventions
- DRUG Oral Lenacapavir
- DRUG Subcutaneous Lenacapavir
- DRUG Teropavimab
- DRUG Zinlirvimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2021-04-08 |
| Est. Completion | 2023-10-26 |
| Phase | Phase 1 |
What the finished NCT04811040 record still lists
NCT04811040 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 4 interventions - of which Oral Lenacapavir is the first listed.
NCT04811040 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04811040 about?
NCT04811040 is a clinical study titled "Study to Evaluate the Safety and Efficacy of Teropavimab and Zinlirvimab in Combination With Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection". The primary objective of this study is to evaluate the safety and tolerability of a combination of the broadly neutralizing antibodies (bNAbs) teropavimab (formerly GS-5423) and zinlirvimab (formerly GS-2872) in combination with the HIV capsid inhibitor lenacapavir (LEN).
What is the current status of trial NCT04811040?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2021-04-08. Estimated completion is 2023-10-26.
What interventions are being tested in trial NCT04811040?
The interventions under investigation include: Oral Lenacapavir (DRUG), Subcutaneous Lenacapavir (DRUG), Teropavimab (DRUG), Zinlirvimab (DRUG).
Who is sponsoring clinical trial NCT04811040?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04811040's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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