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Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics

Studying Dolutegravir/Rilpivirine safety for children and teens.

Recruiting
6-12 years
All
Phase 1/2

This study is about how two medicines, Dolutegravir and Rilpivirine, work together in kids with HIV who are 6-12 years old. HIV is a virus that attacks the immune system. The goal is to see if these medicines, given as one pill, are safe and work well. Children in the study must weigh at least 25 kg and have their HIV under control (less than 50 virus pieces in their blood).

Pharmacokinetics means studying how a drug moves through the body. Safety and tolerability check if the drug has any bad effects and if the kids can handle it. Kids should have been on the same HIV treatment for the past 6 months. They should not have any allergies to the study drugs or certain health problems, like heart issues.

  • Study involves taking a single pill daily.
  • No major changes to current HIV treatment for 6 months required.
  • Participants will be monitored closely for any side effects.
Study details
    HIV Infections

NCT05674656

ViiV Healthcare

12 October 2024

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