Plain-English translation of NCT05069688 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 1 — Testing in a small group (usually 20–80 people) to find a safe dose and watch for side effects.
This trial is testing dolutegravir, an HIV medication, in young children (4 weeks to under 6 years old) who have both HIV and tuberculosis and need treatment for both infections at the same time. Researchers want to understand how the body processes this medication when it's given with standard and higher doses of TB medication, and whether higher TB doses are safe and work well alongside the HIV treatment.
When children have both HIV and TB, the TB medication can interfere with how the body uses HIV medication, potentially making the HIV treatment less effective. This study aims to figure out the right doses of both medications to use together so children get the best care possible.
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Your child will receive standard HIV and TB treatment as part of their regular medical care over 48 weeks. At specific time points, extra blood samples will be drawn to measure how much medication is in your child's bloodstream. For two weeks around week 20, the TB medication dose will be increased and your child will have additional monitoring for safety. You'll attend clinic visits for routine care and monitoring, and your child will have blood tests to check for any side effects throughout the study.
AI-generated summary from trial data · Aug 14, 2026 · Not medical advice
Nigeria