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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

Testing new HIV treatments for kids aged 2-11.

Recruiting
2-11 years
All
Phase 1/2
  • Simplified description (AI rewritten)
  • Technical description (Original)

This study is looking at how well two medicines, Cabotegravir (CAB) and Rilpivirine (RPV), work in children with HIV-1. HIV is a virus that can make people very sick. The study is for kids aged 2 to less than 12 years who are already keeping the virus under control with other medicines. The study will check how the medicines move in the body (called pharmacokinetics or PK), their safety, how the kids handle them (tolerability), and if they are okay with taking them (acceptability). First, kids will take the medicines by mouth and then, they will receive shots (injections). This study will help decide on the right dose for children based on their weight.

  • Duration & Visits: Kids will first take oral medicine and later receive injections, with regular check-ups.
  • Compensation: Participants might receive compensation for their time and travel.
  • Risks: There might be side effects, so kids will be monitored closely.
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Study details
    HIV-1-infection

NCT05660980

National Institute of Allergy and Infectious Diseases (NIAID)

29 March 2025

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