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NCT05660980 · ClinicalTrials.gov registry record · Phase 1
Study of Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living With HIV-1, Two to Less Than 12 Years of Age
A Phase 1 study of HIV-1-infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 90
- Enrollment target
- 12
- Study locations
NCT05660980: Recruiting Phase 1 study of HIV-1-infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT05660980 is a Phase 1 study of HIV-1-infection that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 90 participants, below the 350-participant average among 71 other HIV-1-infection trials with a reported enrollment target (74% lower). The trial reports 12 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05660980, a Phase 1 study of HIV-1-infection, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 90 participants
- Enrollment target
- 12
- Study locations
Study Summary
The purpose of the study is to evaluate the pharmacokinetics (PK), safety, tolerability, and acceptability of a long-acting injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living with HIV-1, Two to Less Than 12 Years of Age
Primary Outcome
Area under the curve from start of dose to 8 hours post dose
Conditions Studied
Interventions
- DRUG Once daily CAB tablet + RPV tablet
- DRUG Long acting CAB injectable + long acting RPV injectable
Study Locations (12)
Other
- Site 12701, Gaborone CRS - Gaborone
- Site 12702, Molepolole CRS - Gaborone
- Site 5073, SOM Federal University Minas Gerais Brazil NICHD CRS - Belo Horizonte
- CRS 5071, Instituto de Puericultura e Pediatria Martagao Gesteira Clinical Research Site - Rio de Janeiro
- Site 8051, Wits RHI Shandukani Research Centre CRS - Johannesburg
- CRS 8052, Soweto IMPAACT - Johannesburg
- CRS 31784, Chiang Mai University HIV Treatment CRS - Chiang Mai
- Site 5116, PHPT-Chiangrai Prachanukroh Hospital NICHD CRS - Chiang Rai
Georgia
- Site 5030, Emory University School of Medicine NICHD CRS - Atlanta
Tennessee
- Site 6501, St. Jude Children's Research Hospital CRS - Memphis
KwaZulu-Natal
- Site 30300 Umlazi CRS Site - Umlazi
Bangkoknoi
- Siriraj Hospital, Mahidol University NICHD CRS (Site #5115) - Bangkok
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2024-01-24 |
| Est. Completion | 2027-07-27 |
| Phase | Phase 1 |
What NCT05660980 shows while recruiting
NCT05660980 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 350-participant average among 71 other HIV-1-infection trials with a reported enrollment target (74% lower).
The record links to 1 condition, with HIV-1-infection appearing as the primary indexed condition, and to 2 interventions - of which Once daily CAB tablet + RPV tablet is the first listed.
NCT05660980 lists 12 locations in 5 states (Other, Georgia, Tennessee).
Frequently Asked Questions
What is clinical trial NCT05660980 about?
NCT05660980 is a clinical study titled "Study of Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living With HIV-1, Two to Less Than 12 Years of Age". The purpose of the study is to evaluate the pharmacokinetics (PK), safety, tolerability, and acceptability of a long-acting injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living with HIV-1, Two to Less Than 12 Years of Age
What is the current status of trial NCT05660980?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 90 participants. The study started on 2024-01-24. Estimated completion is 2027-07-27.
What conditions does trial NCT05660980 study?
This clinical trial studies the following conditions: HIV-1-infection.
What interventions are being tested in trial NCT05660980?
The interventions under investigation include: Once daily CAB tablet + RPV tablet (DRUG), Long acting CAB injectable + long acting RPV injectable (DRUG).
Who is sponsoring clinical trial NCT05660980?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05660980 being conducted?
This trial has 12 study locations across Georgia, Tennessee, KwaZulu-Natal, Bangkoknoi. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05660980's enrollment target sits among peer trials
90 34th of 71 higher than 38 of 71 other HIV-1-infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV-1-infection 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.
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