What side effects are associated with this type of intervention?

Fostemsavir, used in HIV treatment, can cause side effects such as nausea, headache, diarrhea, and abdominal pain. Other common treatments for HIV, such as antiretroviral therapy (ART), may cause side effects including fatigue, dizziness, insomnia, and gastrointestinal issues like vomiting and diarrhea. Long-term use of ART can also lead to more serious side effects such as liver toxicity, kidney problems, and bone density loss.

What prior FDA approvals exist?

Fostemsavir, which targets the gp120 subunit of the HIV-1 envelope glycoprotein to prevent viral attachment and entry, represents a novel approach in HIV treatment. Prior FDA-approved treatments for HIV include a variety of antiretroviral drugs such as reverse transcriptase inhibitors (e.g., zidovudine, lamivudine), protease inhibitors (e.g., ritonavir, lopinavir), integrase inhibitors (e.g., raltegravir, dolutegravir), and entry inhibitors like maraviroc, which blocks the CCR5 co-receptor on the host cell. These treatments have significantly improved the management of HIV by targeting different stages of the viral life cycle.

What other types of research exist?

Promising novel alternatives to Fostemsavir for HIV patients include long-acting injectable antiretrovirals like Cabotegravir and Rilpivirine, which offer the convenience of less frequent dosing. Additionally, Lenacapavir, a capsid inhibitor, is another innovative option that has shown potential in clinical trials for its unique mechanism of action and long-acting properties.

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Fostemsavir for HIV

Q: What is the mechanism of action of this treatment?

Common treatments for HIV, such as antiretroviral therapy (ART), work by inhibiting different stages of the HIV life cycle, including reverse transcription, integration, and protease activity. Fostemsavir, an entry inhibitor, specifically binds to the gp120 subunit of the HIV-1 envelope glycoprotein, preventing the virus from attaching to and entering host cells. This is particularly important for HIV patients who are virologically suppressed but have not achieved optimal CD4 T-cell recovery, as it can enhance immune function and improve overall health outcomes.

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

Must not have

History of any malignancy ≤5 years

Use of systemic corticosteroids or other immunomodulatory agents in the last 14 days prior to study entry

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 24 and 48

Awards & highlights

No Placebo-Only Group

Pivotal Trial

All Individual Drugs Already Approved

Drug Has Already Been Approved

Summary

This trial is testing whether adding Fostemsavir to the treatment of HIV patients with stable virus levels but poor immune health can improve their immune system. Fostemsavir helps by blocking the virus from entering and destroying immune cells.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had cancer within the last 5 years.

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I haven't taken steroids or immune system medications in the last 14 days.

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I have had radiation or chemotherapy before.

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My liver disease is not stable or I have severe liver disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 and 48 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for HIV, such as antiretroviral therapy (ART), work by inhibiting different stages of the HIV life cycle, including reverse transcription, integration, and protease activity. Fostemsavir, an entry inhibitor, specifically binds to the gp120 subunit of the HIV-1 envelope glycoprotein, preventing the virus from attaching to and entering host cells. This is particularly important for HIV patients who are virologically suppressed but have not achieved optimal CD4 T-cell recovery, as it can enhance immune function and improve overall health outcomes.