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

• Status: Not yet recruiting
• Trial end date: 2023-07-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Orlando Immunology Center
• Collaborator: ViiV Healthcare
• Treatments: Fostemsavir

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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