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Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics

Studying Dolutegravir/Rilpivirine safety in children.

Recruiting
6-12 years
All
Phase 1/2

This study is for children aged 6 to 12 years with HIV-1, a virus that attacks the immune system. It tests a new pill combining two drugs, Dolutegravir and Rilpivirine, to see how the body handles it (pharmacokinetics), how safe it is, and if it works well without causing bad side effects (tolerability). To join, kids must weigh at least 25 kilograms and have been on the same HIV medicine for the past six months, with no signs of the virus in their blood.

Key points to consider before participation:

  • Study Length: Participation involves 24 weeks of study treatment.
  • Visits: Regular visits to the study site are required for monitoring and tests.
  • Risks: Possible side effects and drug interactions need to be considered.

Children with a history of certain drug resistances or medical conditions, like liver disease or heart problems, are not eligible. The study aims to find a simpler, effective treatment for young patients with HIV-1.

Study details
    HIV Infections

NCT05674656

ViiV Healthcare

12 October 2024

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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