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)
Phase I/II Study of the Safety, Tolerability, Acceptability, and Pharmacokinetics 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
🩺 Plain-English Summary (8th-Grade Level)
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
Who can join: Review the eligibility criteria below.
Location: Site 5030, Emory University School of Medicine NICHD CRS — Atlanta, Georgia
Age range: 2 Years to 11 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (12 Sites)
- Site 5030, Emory University School of Medicine NICHD CRS — Atlanta, Georgia
- Site 6501, St. Jude Children's Research Hospital CRS — Memphis, Tennessee
- 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 30300 Umlazi CRS Site — Umlazi, KwaZulu-Natal
- CRS 8052, Soweto IMPAACT — Johannesburg,
- Site 8051, Wits RHI Shandukani Research Centre CRS — Johannesburg,
- Siriraj Hospital, Mahidol University NICHD CRS (Site #5115) — Bangkok, Bangkoknoi
- CRS 31784, Chiang Mai University HIV Treatment CRS — Chiang Mai,
- Site 5116, Chiangrai Prachanukroh Hospital NICHD CRS — Chiang Rai,
📞 Contact the Study Coordinator
Phone: (919) 321-3540
Email: rscheckter@fhi360.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in HIV-1-infection
- Study of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1 — Washington D.C., District of Columbia
- Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen — Berkeley, California
- Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1 — Birmingham, Alabama
- Impact of HIV-1 and Aging on Mucosal Vaccine Responses — Aurora, Colorado
- Study of Oral Weekly Lepetegravir (Formerly GS-1720) and Lenacapavir Pacfosacil (Formerly GS-4182) Versus Biktarvy in People With HIV-1 Who Are Virologically Suppressed — Birmingham, Alabama
- Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy — Phoenix, Arizona
Explore by condition: All HIV-1-infection clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.