ACTIVE_NOT_RECRUITING

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

Conditions

HIV-1-infection CD4 recovery immunologic recovery immunologic non responder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2022-06-15

Study Completion:2026-02-13

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05220358

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.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Principal Investigator

Charlotte-Paige M Rolle, MD, MPH

PRINCIPAL_INVESTIGATOR

Orlando Immunology Center

Study Locations (Sites)

Orlando Immunology Center

Orlando, Florida, 32803

United States

Collaborators and Investigators

Sponsor: Orlando Immunology Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-15

Study Completion Date2026-02-13

Study Record Updates

Study Start Date2022-06-15

Study Completion Date2026-02-13

Terms related to this study

Keywords Provided by Researchers

CD4 recovery
immunologic recovery
immunologic non responder

Additional Relevant MeSH Terms

HIV-1-infection