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Changes in Immunologic Parameters Following the Addition of Fostemsavir in Virologically Suppressed Immunologic Non-responders Living With HIV-the RECOVER Study

NCT05220358 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-08-03

No results posted yet for this 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

Conditions

Interventions

DRUG

Fostemsavir 600 MG [Rukobia]

FTR 600 mg PO BID added to daily suppressive HIV regimen

Sponsors & Collaborators

  • ViiV Healthcare

    collaborator INDUSTRY

  • Orlando Immunology Center

    lead OTHER

Principal Investigators

  • Charlotte-Paige M Rolle, MD, MPH · Orlando Immunology Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-15
Primary Completion
2026-02-13
Completion
2026-02-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05220358 on ClinicalTrials.gov