Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING 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

NCT05660980 · View on ClinicalTrials.gov ↗

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

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05660980

The ClinicalTrials.gov registry entry for NCT05660980 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05660980 reports 12 study locations spanning 5 distinct geographic areas — top geographies include Other, Georgia, Tennessee. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05660980?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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