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

OIC_010

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

2022-05-01

2024-07-31

2024-08-31

Recruiting

Early phase I

50

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

2023-11-03