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NCT04542070 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Efficacy and Safety of Cabotegravir (CAB) Long Acting (LA) Plus (+) Rilpivirine (RPV) LA Versus BIKTARVY® (BIK) in Participants With Human Immunodeficiency Virus (HIV)-1 Who Are Virologically Suppressed
A Phase 3 study, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 3
- Development phase
- 687
- Enrollment target
NCT04542070: Completed Phase 3 study, sponsored by ViiV Healthcare.
NCT04542070 is a Phase 3 study that has completed, run by ViiV Healthcare. The registered enrollment target is 687 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (11% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04542070, a Phase 3 study, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 687 participants
- Enrollment target
Study Summary
This study is designed to assess the antiviral activity and safety of a two-drug regimen of CAB LA + RPV LA compared with maintenance of BIK. BIKTARVY is a registered trademark of Gilead Sciences.
Primary Outcome
Percentage of participants with plasma HIV 1 RNA \>= 50 c/mL at month 12 was assessed using the food and drug administration (FDA) snapshot algorithm. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK
Interventions
- DRUG Cabotegravir Tablets
- DRUG Rilpivirine Tablets
- DRUG Cabotegravir Injectable Suspension (CAB LA)
- DRUG Rilpivirine Injectable Suspension (RPV LA)
- DRUG BIKTARVY Tablets (BIK)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 687 participants |
| Start Date | 2020-11-09 |
| Est. Completion | 2023-04-17 |
| Phase | Phase 3 |
What the finished NCT04542070 record still lists
NCT04542070 is an interventional study that assigns participants to a tested intervention. The registered 687 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (11% lower).
The record links to 0 conditions, and to 5 interventions - of which Cabotegravir Tablets is the first listed.
NCT04542070 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04542070 about?
NCT04542070 is a clinical study titled "A Study to Evaluate Efficacy and Safety of Cabotegravir (CAB) Long Acting (LA) Plus (+) Rilpivirine (RPV) LA Versus BIKTARVY® (BIK) in Participants With Human Immunodeficiency Virus (HIV)-1 Who Are Virologically Suppressed". This study is designed to assess the antiviral activity and safety of a two-drug regimen of CAB LA + RPV LA compared with maintenance of BIK. BIKTARVY is a registered trademark of Gilead Sciences.
What is the current status of trial NCT04542070?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 687 participants. The study started on 2020-11-09. Estimated completion is 2023-04-17.
What interventions are being tested in trial NCT04542070?
The interventions under investigation include: Cabotegravir Tablets (DRUG), Rilpivirine Tablets (DRUG), Cabotegravir Injectable Suspension (CAB LA) (DRUG), Rilpivirine Injectable Suspension (RPV LA) (DRUG), BIKTARVY Tablets (BIK) (DRUG).
Who is sponsoring clinical trial NCT04542070?
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 NCT04542070's enrollment target sits among peer trials
687 525th of 2000 higher than 1,476 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
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