Status:
ACTIVE_NOT_RECRUITING
Changes in Immunologic Parameters Following the Addition of Fostemsavir in Virologically Suppressed Immunologic Non-responders Living With HIV-the RECOVER Study
Lead Sponsor:
Orlando Immunology Center
Collaborating Sponsors:
ViiV Healthcare
Conditions:
HIV-1-infection
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 expe...
Detailed Description
In July 2020 the FDA approved fostemsavir (FTR), a prodrug of its active moiety temsavir which is a first-in class attachment inhibitor to be used in combination with other antiretrovirals (ARVs) to t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 13 2026
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05220358
Start Date
June 15 2022
End Date
February 13 2026
Last Update
August 3 2025
Active Locations (1)
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1
Orlando Immunology Center
Orlando, Florida, United States, 32803