Evaluating the effects of Fostemsavir on immune recovery in HIV patients
Changes in Immunologic Parameters Following the Addition of Fostemsavir in Virologically Suppressed Immunologic Non-responders Living With HIV-the RECOVER Study
This study is testing if adding Fostemsavir to the treatment of HIV patients with low CD4 T-cell counts can help improve their immune system recovery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Orlando Immunology Center Academic / other |
| Drugs / interventions | chemotherapy, radiation, ibalizumab |
| Locations | 1 site (Orlando, Florida) |
| Trial ID | NCT05220358 on ClinicalTrials.gov |
What this trial studies
The RECOVER study aims to assess the impact of adding Fostemsavir (Rukobia) to the treatment regimen of HIV patients who are virologically suppressed but have not achieved optimal CD4 T-cell recovery. This self-controlled case series will measure changes in immunologic parameters, including CD4 T-cell count and CD4/CD8 ratio, among participants who have been on a stable antiretroviral regimen for at least six months. The study focuses on patients with a CD4+ T-cell count below 350 cells/mm3, evaluating whether Fostemsavir can enhance their immune response. Participants will take Fostemsavir 600 mg twice daily alongside their existing treatment.
Who should consider this trial
Good fit: Ideal candidates are HIV-1 infected individuals aged 18-65 with a stable ARV regimen and a CD4+ T-cell count below 350 cells/mm3.
Not a fit: Patients with newly diagnosed HIV-1 infection or those with active HBV or HCV co-infection may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved immune recovery for HIV patients who have struggled to regain CD4 T-cell counts.
How similar studies have performed: Previous studies have shown promising results with Fostemsavir in improving CD4 T-cell recovery in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Orlando, Florida
- Orlando Immunology Center — Orlando, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Charlotte-Paige M Rolle, MD, MPH — Orlando Immunology Center
- Study coordinator: Wendy Wert
- Email: wwert@oicorlando.com
- Phone: 4076473960
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.