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Fostemsavir for HIV

Phase 4
Recruiting
Led By Charlotte-Paige M Rolle, MD, MPH
Research Sponsored by Orlando Immunology Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 24 and 48
Awards & highlights

Study Summary

This trial will test whether adding the drug Fostemsavir to a stable HIV regimen can increase immunologic parameters in patients who never experience optimal CD4 T-cell count recovery.

Who is the study for?
This trial is for HIV-1 infected adults aged 18-65 with stable insurance, who have been on a consistent ARV regimen for over six months and have maintained low viral loads but poor CD4 T-cell count recovery. Participants must have had less than 350 cells/mm3 while on ARVs for at least two years and attended at least two clinic visits in the past year.Check my eligibility
What is being tested?
The RECOVER study tests if adding Fostemsavir (Rukobia) to a stable HIV treatment helps improve immune system markers like CD4 T-cell counts in patients whose levels haven't risen sufficiently despite having their virus under control.See study design
What are the potential side effects?
While specific side effects are not listed here, Fostemsavir may cause common drug-related adverse reactions such as headache, diarrhea, nausea, rash and potential increases in liver enzymes which will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My CD4+T-cell count is below 350, despite being on ARVs for 2+ years.
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I am willing to add FTR 600 mg twice daily to my current HIV treatment.
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I am HIV-1 positive.
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I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 and 48 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 and 48 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Assessment of HIV or ART-related symptoms after the addition of fostemsavir to baseline ARV regimen
Assessment of health related quality of life after the addition of fostemsavir to baseline ARV regimens
Assessment of treatment satisfaction in subjects who have fostemsavir added to their baseline ARV regimen
+9 more
Other outcome measures
Evaluation of gp120 detection and correlation with reservoir and inflammatory biomarkers
Identification of biomarkers that may predict CD4 recovery and Immunologic non response
Impact of fostemsavir treatment on inflammatory, cellular functional, and viral reservoir biomarkers in immunologic non responders

Trial Design

1Treatment groups
Experimental Treatment
Group I: FTR+suppressive regimenExperimental Treatment1 Intervention
addition of fostemsavir 600 mg PO BID to the stable suppressive HIV regimen in immunologic non responders

Find a Location

Who is running the clinical trial?

Orlando Immunology CenterLead Sponsor
5 Previous Clinical Trials
132 Total Patients Enrolled
ViiV HealthcareIndustry Sponsor
359 Previous Clinical Trials
468,598 Total Patients Enrolled
Charlotte-Paige M Rolle, MD, MPHPrincipal InvestigatorOrlando Immunology Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research protocol admit individuals who are of advanced age?

"This medical trial welcomes individuals from the age of consent to 65 years old."

Answered by AI

Is there availability for potential participants in this experiment?

"Affirmative. Information published on clinicaltrials.gov reveals that this medical trial has been actively recruiting since May 1st 2022 and the most recent update was released on September 20th 2022. The study is seeking 50 patients from a single location for participation."

Answered by AI

Am I able to register for this medical experiment?

"This investigation is recruiting 50 individuals with HIV-1 infection between the permissible ages of 18 and 65. Candidates should have a documented plasma HIV-1 RNA count lower than 50 c/mL, CD4+ T cell counts below 350 cells/mm3 during ARV treatment for at least 2 years, stable health insurance plans, must add FTR 600 mg twice daily to their existing antiretroviral regimen for 6 months or more before screening, and attend a minimum of two clinic visits within 12 months prior to being accepted into this trial."

Answered by AI

How detrimental is the FTR+suppressive regimen to individuals?

"With Phase 4 trials complete, the safety of FTR+suppressive regimen was rated a 3 due to its approval status."

Answered by AI

How many participants has this research enrolled thus far?

"Affirmative. The records available on clinicaltrials.gov verify that this research is actively recruiting subjects, having been posted on May 1st 2022 and updated most recently in September 20th of the same year. Approximately 50 people must be sourced from a single medical site."

Answered by AI
~8 spots leftby Jul 2024