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NCT04648280 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of HIV Infections With Multi Drug Resistant Virus, sponsored by PENTA Foundation.
- Active
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 8
- Study locations
NCT04648280: Active Phase 1 study of HIV Infections With Multi Drug Resistant Virus, sponsored by PENTA Foundation.
NCT04648280 is a Phase 1 study of HIV Infections With Multi Drug Resistant Virus that is active but no longer recruiting, run by PENTA Foundation. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. The trial reports 8 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04648280, a Phase 1 study of HIV Infections With Multi Drug Resistant Virus, is active but no longer recruiting, sponsored by PENTA Foundation.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 8
- Study locations
Study Summary
In the SHIELD study, the study sponsor seeks to assess safety, PK and antiviral activity for children and adolescents with dual or triple class resistance. It will also assess the acceptability and swallowability of formulation among the pediatric population. The dose selection of FTR for children and adolescents ≥20kg utilized a population pharmacokinetic (POP PK) model-based approach to achieve similar adult TMR exposures following FTR 600mg BID administration with combination therapy that was demonstrated to be safe and effective in the FTR Phase 3 BRIGHTE study in HTE patients.
Conditions Studied
Interventions
- DRUG Fostemsavir
Study Locations (8)
Other
- Hospital Geral de Nova Iguaçu - Nova Iguaçu
- Hospital Federal dos Servidores do Estado - Rio de Janeiro
- FAM-CRU - Cape Town
- King Edward VIII Hospital - Durban
- Rahima Moosa Mother and Child Hospital - Johannesburg
- Wits Reproductive Health and HIV Institutel - Johannesburg
- PHRU - Soweto
Georgia
- Children's Healthcare of Atlanta - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2022-06-30 |
| Est. Completion | 2028-12 |
| Phase | Phase 1 |
What the registry record for NCT04648280 still lists
NCT04648280 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 1 condition, with HIV Infections With Multi Drug Resistant Virus appearing as the primary indexed condition, and to 1 intervention - of which Fostemsavir is the first listed.
NCT04648280 lists 8 locations in 2 states (Other, Georgia).
Frequently Asked Questions
What is clinical trial NCT04648280 about?
NCT04648280 is a clinical study titled "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". In the SHIELD study, the study sponsor seeks to assess safety, PK and antiviral activity for children and adolescents with dual or triple class resistance. It will also assess the acceptability and swallowability of formulation among the pediatric population. The dose selection of FTR for children a...
What is the current status of trial NCT04648280?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2022-06-30. Estimated completion is 2028-12.
What conditions does trial NCT04648280 study?
This clinical trial studies the following conditions: HIV Infections With Multi Drug Resistant Virus.
What interventions are being tested in trial NCT04648280?
The interventions under investigation include: Fostemsavir (DRUG).
Who is sponsoring clinical trial NCT04648280?
This trial is sponsored by PENTA Foundation, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04648280 being conducted?
This trial has 8 study locations across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04648280's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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