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

Description

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

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Study Overview

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Study Details

Study overview

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

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

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

Condition
HIV-1-infection
Intervention / Treatment

-

Contacts and Locations

Orlando

Orlando Immunology Center, Orlando, Florida, United States, 32803

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Orlando Immunology Center,

Charlotte-Paige M Rolle, MD, MPH, PRINCIPAL_INVESTIGATOR, Orlando Immunology Center

Study Record Dates

2024-08-31