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NCT05220358 · ClinicalTrials.gov registry record · Phase 4
Changes in Immunologic Parameters Following the Addition of Fostemsavir in Virologically Suppressed Immunologic Non-responders Living With HIV-the RECOVER Study
A Phase 4 study of HIV-1-infection, sponsored by Orlando Immunology Center.
- Active
- Registry status
- Phase 4
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT05220358: Active Phase 4 study of HIV-1-infection, sponsored by Orlando Immunology Center.
NCT05220358 is a Phase 4 study of HIV-1-infection that is active but no longer recruiting, run by Orlando Immunology Center. The registered enrollment target is 25 participants, below the 351-participant average among 71 other HIV-1-infection trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05220358, a Phase 4 study of HIV-1-infection, is active but no longer recruiting, sponsored by Orlando Immunology Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
The RECOVER study is a self-controlled case series to evaluate whether the addition of Fostemsavir (Rukobia) to a stable HIV regimen in virologically suppressed patients living with HIV who never experience optimal CD4 T-cell count recovery can result in meaningful increases in different immunologic parameters such as CD4 T-cell count, CD4 T-cell percentage and CD4/CD8 ratio
Primary Outcome
mean and median change in CD4+T-cell count after the addition of fostemsavir to baseline ARV regimens in virologically suppressed immunologic non responders using pre-fostemsavir values as controls
Conditions Studied
Interventions
- DRUG Fostemsavir 600 MG [Rukobia]
Study Locations (1)
Florida
- Orlando Immunology Center - Orlando
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2022-06-15 |
| Est. Completion | 2026-02-13 |
| Phase | Phase 4 |
What the registry record for NCT05220358 still lists
NCT05220358 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 351-participant average among 71 other HIV-1-infection trials with a reported enrollment target (93% lower).
The record links to 1 condition, with HIV-1-infection appearing as the primary indexed condition, and to 1 intervention - of which Fostemsavir 600 MG [Rukobia] is the first listed.
NCT05220358 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT05220358 about?
NCT05220358 is a clinical study titled "Changes in Immunologic Parameters Following the Addition of Fostemsavir in Virologically Suppressed Immunologic Non-responders Living With HIV-the RECOVER Study". The RECOVER study is a self-controlled case series to evaluate whether the addition of Fostemsavir (Rukobia) to a stable HIV regimen in virologically suppressed patients living with HIV who never experience optimal CD4 T-cell count recovery can result in meaningful increases in different immunologic...
What is the current status of trial NCT05220358?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 25 participants. The study started on 2022-06-15. Estimated completion is 2026-02-13.
What conditions does trial NCT05220358 study?
This clinical trial studies the following conditions: HIV-1-infection.
What interventions are being tested in trial NCT05220358?
The interventions under investigation include: Fostemsavir 600 MG [Rukobia] (DRUG).
Who is sponsoring clinical trial NCT05220358?
This trial is sponsored by Orlando Immunology Center, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05220358 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV-1-infection
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05220358's enrollment target sits among peer trials
25 61st of 71 higher than 9 of 71 other HIV-1-infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV-1-infection 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.
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