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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-1 treatments for kids aged 2 to under 12.

Recruiting
2-11 years
All
Phase 1/2

This study tests two medicines, Cabotegravir and Rilpivirine, for children with HIV-1, ages 2 to less than 12 who are already on HIV treatment. The study will check how the medicines work in the body, their safety, and if they are easy to use. First, the children will take the medicines by mouth, then they will get long-lasting shots. The goal is to find out the best dose based on the child's weight.

To join, the child must have taken their current HIV medicine for at least six months and be healthy enough for the study. The child can't join if they've had certain health issues or medicine reactions. Parents or guardians must agree to let their child participate, and they themselves might answer some questions during the study.

  • Study Length: Participants will first take oral medicine, then switch to injections.
  • Eligibility: Children must be between 2 and less than 12 years old, already on stable HIV treatment.
  • Risks and Compensation: Safety will be monitored. Compensation details, if any, are not specified.

This study helps researchers understand how these medicines work in young children and if they are safe and effective.

Study details
    HIV-1-infection

NCT05660980

National Institute of Allergy and Infectious Diseases (NIAID)

29 March 2025

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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