NCT05220358Active, not recruitingPhase 4
Changes in Immunologic Parameters Following the Addition of Fostemsavir in Virologically Suppressed Immunologic Non-responders Living With HIV-the RECOVER Study
Source: ClinicalTrials.gov · Last updated 3 Aug 2025
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 25 (actual)
- First submitted
- 31 Jan 2022
- Start date
- 15 Jun 2022
- Primary completion date
- 13 Feb 2026
- Lead sponsor
- Orlando Immunology Center
- Diseases
- HIV
- NCT number
- NCT05220358
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 25
- From 15 Jun 2022 to the primary completion date, 13 Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Newly or recently diagnosed HIV-1 infection defined as HIV-1 infection diagnosed in the prior 6 months
- Use of systemic corticosteroids or other immunomodulatory agents in the last 14 days prior to study entry
Other illness
- Active HBV or HCV co-infection
- Unstable liver disease or Child-Pugh C liver disease
- History of autoimmune disease
- History of radiation or cytotoxic chemotherapy
Lab values
- 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
Age
- History of any malignancy ≤5 years
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Orlando Immunology Center Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.