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Viral Entry Inhibitor

Fostemsavir for HIV Infection

Phase 1 & 2
Recruiting
Research Sponsored by PENTA Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Antiretroviral-experienced with documented historical or baseline resistance to one or more agents in at least two classes. All resistance has to be properly documented
Documented resistance to at least one component of the current failing regimen per screening resistance testing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 1, 4, 12, 24, 48
Awards & highlights

Study Summary

This trial will assess safety, antiviral activity, and how well kids and teens 20kg+ can take a drug to treat HIV with multiple resistance.

Who is the study for?
This trial is for HIV-1 infected children and adolescents aged 6 to less than 18 years, weighing at least 20 kg, who are failing their current antiretroviral therapy with documented resistance to multiple drug classes. Participants must have a viral load ≥1000 c/mL and access to at least one fully active antiviral agent in two or more classes. Girls post-menarche must not be pregnant or breastfeeding and agree to use contraception.Check my eligibility
What is being tested?
The SHIELD study tests the safety, pharmacokinetics (how the body processes the drug), and anti-HIV activity of Fostemsavir plus optimized background therapy in youths resistant to standard treatments. It also evaluates how well kids can take this new formulation based on adult studies showing effectiveness.See study design
What are the potential side effects?
While specific side effects for children aren't detailed here, Fostemsavir in adults has been associated with nausea, diarrhea, headache, fatigue, rash and potential elevation of liver enzymes which could indicate liver injury.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have HIV and my treatment history shows resistance to drugs from at least two different classes.
Select...
My current treatment is not working according to recent tests.
Select...
I am an HIV-1 infected child aged 6 to less than 18 years and weigh at least 20 kg.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 1, 4, 12, 24, 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 1, 4, 12, 24, 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC(0-tau)
Cmax
Ctau of temsavir across weight bands
+1 more
Secondary outcome measures
Change in log10 HIV-1 RNA from baseline
Emergence of genotypic or phenotypic resistance to Temsavir and components of OBT
Occurrence of WHO 3 or 4 defining events, or death
+3 more

Side effects data

From 2017 Phase 2 trial • 254 Patients • NCT01384734
19%
Headache
19%
Diarrhoea
16%
Nasopharyngitis
14%
Upper respiratory tract infection
14%
Urinary tract infection
11%
Influenza
11%
Bronchitis
10%
Back pain
10%
Nausea
9%
Pharyngitis
9%
Herpes zoster
9%
Cough
9%
Arthralgia
8%
Vomiting
8%
Rash
8%
Hypertension
7%
Abdominal pain
7%
Pain in extremity
7%
Insomnia
6%
Fatigue
6%
Gastroenteritis
6%
Dyspepsia
6%
Constipation
5%
Lower respiratory tract infection
5%
Dizziness
5%
Myalgia
5%
Blood creatine phosphokinase increased
4%
Onychomycosis
3%
Sinusitis
3%
Alanine aminotransferase increased
2%
Overdose
1%
Obstructive airways disorder
1%
Osteonecrosis
1%
Disseminated tuberculosis
1%
Gun shot wound
1%
Meningoencephalitis herpetic
1%
Anal abscess
1%
Bone tuberculosis
1%
Lymphangitis
1%
Oral candidiasis
1%
Oesophageal varices haemorrhage
1%
Intervertebral disc protrusion
1%
Acute stress disorder
1%
Depression
1%
Syncope
1%
Cholecystitis chronic
1%
Adenocarcinoma of salivary gland
1%
Neutropenia
1%
Blood bilirubin increased
1%
Ocular icterus
1%
Sepsis
1%
Accidental overdose
1%
Suicide attempt
1%
Post herpetic neuralgia
1%
Ovarian neoplasm
1%
Vertigo
1%
Hysterectomy
1%
Deep vein thrombosis
1%
Completed suicide
1%
Cellulitis
1%
Cellulitis staphylococcal
1%
Decreased appetite
1%
Abortion spontaneous
1%
Acute kidney injury
100%
80%
60%
40%
20%
0%
Study treatment Arm
FTR/RAL/TDF Total
ATV/r/RAL/TDF

Trial Design

1Treatment groups
Experimental Treatment
Group I: FostemsavirExperimental Treatment1 Intervention
Fostemsavir in combination with optimized background therapy (OBT) in HIV-1 infected children and adolescents who are failing their current combination antiretroviral therapy (cART) and have dual- or triple-class ARV resistance

Find a Location

Who is running the clinical trial?

ViiV HealthcareIndustry Sponsor
360 Previous Clinical Trials
468,519 Total Patients Enrolled
PHPT FoundationUNKNOWN
Hospital Universitario 12 de OctubreOTHER
75 Previous Clinical Trials
49,291 Total Patients Enrolled

Media Library

Fostemsavir (Viral Entry Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04648280 — Phase 1 & 2
HIV Infection Research Study Groups: Fostemsavir
HIV Infection Clinical Trial 2023: Fostemsavir Highlights & Side Effects. Trial Name: NCT04648280 — Phase 1 & 2
Fostemsavir (Viral Entry Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04648280 — Phase 1 & 2

Frequently Asked Questions

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

What criteria must individuals meet in order to be eligible for participation in this clinical trial?

"The criteria for entering this trial consists of being 6-17 years old, with a diagnosis of HIV infection. This research initiative is looking to enroll approximately 60 people in total."

Answered by AI

In what contexts is Fostemsavir typically prescribed to patients?

"Fostemsavir is a useful pharmacological tool for those treating HIV, antiretroviral agents and patients already undergoing anti-retroviral treatment."

Answered by AI

Is the enrollment criterion of this trial limited to individuals aged 45 or above?

"To be considered for this clinical trial, patients must fall within the age range of 6 to 17. Additionally, there are 115 studies available for those below 18 years old and 343 trials open to subjects over 65."

Answered by AI

Are there any slots open for participation in this clinical study?

"According to clinicaltrials.gov, this medical trial remains open for recruitment and was initially made public on June 30th 2022 with a recent edit occurring on March 28th 2023."

Answered by AI

How many participants have been recruited for this clinical experiment?

"Affirmative. The study's listing on clinicaltrials.gov indicates that the trial is actively recruiting participants, having first been posted on June 30th 2022 and most recently modified on March 28th 2023. 60 patients must be enrolled at 7 sites for this experiment to proceed as planned."

Answered by AI

What locations have been selected to host this experiment?

"Presently, there are 7 open clinical trial sites that individuals can join. Locations include Atlanta, Mexico City, Durban and other nearby cities; it is recommended to select the closest site for convenience purposes if one chooses to partake in the study."

Answered by AI

Is this study breaking new ground in the field?

"Presently, two research projects involving Fostemsavir are active across 25 countries and 61 cities. The first trial commenced in 2015 with the sponsorship of ViiV Healthcare, eventually culminating in Phase 3 drug approval after 371 patients were evaluated. In total since 2015, 17 studies have been completed for this medication."

Answered by AI

Are there any other trials which have evaluated the efficacy of Fostemsavir?

"Currently, two clinical trials researching Fostemsavir are in progress. One of these is undergoing Phase 3 testing. With 120 different sites available, Washington D.C. serves as the primary hub for this experiment's research and development activities."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Safety and Pharmacokinetics Evaluation of Fostemsavir + (OBT) in HIV-1 Infected Children and Adolescents Who Are Failing Their cART and Have Dual- or Triple-class Antiretroviral Resistance
2022. "Safety and Pharmacokinetics Evaluation of Fostemsavir + (OBT) in HIV-1 Infected Children and Adolescents Who Are Failing Their cART and Have Dual- or Triple-class Antiretroviral Resistance". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04648280.
~22 spots leftby Jun 2025
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