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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

Active Not RecruitingPhase 4

Sponsor: Orlando Immunology Center

Conditions: HIV-1-infection

Interventions: Fostemsavir 600 MG [Rukobia]

Countries: United States

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

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (1)

Orlando, Florida, United States