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

NCT05220358 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: OIC_010
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

HIV-1-infection

Keywords

CD4 recovery; immunologic recovery; immunologic non responder

Outcome Measures

Primary Outcomes (1)

• Mean and median change in CD4+T-cell count

  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

  48 weeks

Secondary Outcomes (12)

• Mean and median change in CD4+T-cell count

  24 weeks

• mean and median change in CD4+T-cell count percentage

  24 and 48 weeks

• mean and median change in CD4/CD8 ratio

  24 and 48 weeks

• Proportion with virologic failure defined as an HIV-1 RNA≥50 c/mL

  24 and 48 weeks

• Safety and tolerability of fostemsavir

  Weeks 24 and 48

Other Outcomes (3)

• Impact of fostemsavir treatment on inflammatory, cellular functional, and viral reservoir biomarkers in immunologic non responders

  Weeks 24 and 48

• Identification of biomarkers that may predict CD4 recovery and Immunologic non response

  Weeks 24 and 48

• Evaluation of gp120 detection and correlation with reservoir and inflammatory biomarkers

  Weeks 24 and 48

Study Arms (1)

FTR+suppressive regimen

EXPERIMENTAL

addition of fostemsavir 600 mg PO BID to the stable suppressive HIV regimen in immunologic non responders

Drug: Fostemsavir 600 MG [Rukobia]

Interventions

Fostemsavir 600 MG [Rukobia] DRUG

FTR 600 mg PO BID added to daily suppressive HIV regimen

FTR+suppressive regimen

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-1 infected men or women
• Aged 18-65
• Stable insurance plan
• Documented plasma HIV-1 RNA \< 50 c/mL x 2 within the last year prior to screening
• Must be on a stable ARV regimen for ≥6 months prior to screening
• CD4+T-cell count\<350 cells/mm3 while on ARVs for at least 2 years
• Must be willing to add FTR 600 mg twice daily to their current antiretroviral regimen
• Must have attended ≥ 2 clinic visits in the 12 months prior to screening

You may not qualify if:

• Newly or recently diagnosed HIV-1 infection defined as HIV-1 infection diagnosed in the prior 6 months
• Active HBV or HCV co-infection
• Unstable liver disease or Child-Pugh C liver disease
• History of autoimmune disease
• History of any malignancy ≤5 years
• History of radiation or cytotoxic chemotherapy
• Use of systemic corticosteroids or other immunomodulatory agents in the last 14 days prior to study entry
• Confirmed QT value \> 500 msec at Screening or Day 1 or confirmed QTcF value \> 470 msec for women and \> 450 msec for men at Screening or Day 1

Sponsors & Collaborators

• Orlando Immunology Center: lead
• ViiV Healthcare: collaborator

Study Sites (1)

Orlando Immunology Center

Orlando, Florida, 32803, United States

Location

MeSH Terms

Interventions

fostemsavir

Study Officials

• Charlotte-Paige M Rolle, MD, MPH

  Orlando Immunology Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: self-controlled case series to evaluate the change in immunologic parameters following the addition of FOS to baseline ARV regimens among virologically suppressed INRs through 48 weeks of treatment.

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: February 2, 2022
• Study Start: June 15, 2022
• Primary Completion: February 13, 2026
• Study Completion: February 13, 2026
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)