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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 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.

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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

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

FieldValue
Enrollment Target 90 participants
Start Date 2024-01-24
Est. Completion 2027-07-27
Phase Phase 1

What the Registry Record Tells You About NCT05660980

The ClinicalTrials.gov registry entry for NCT05660980 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 350-participant average among 71 other HIV-1-infection trials with a reported enrollment target (74% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

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 reports 12 study locations spanning 5 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.