Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT05122767
Eligibility Criteria:
Inclusion criteria include:
* Age 3 months through 17 years
* Weight \> 3 kg
* Documented HIV infection by DNA polymerase chain reaction (PCR) or plasma RNA-PCR if \<18 months and by HIV-ELISA if 18 months and confirmed with a DNA PCR or RNA-PCR from an independent sample
* Undetectable HIV-1 viral load
Exclusion criteria
* Confirmed or suspected TB disease (evidenced by symptoms and/or clinical exam findings and/or chest radiographic findings suggestive of TB, positive mycobacterial culture or molecular TB testing, or currently on TB treatment for active TB disease)
* Likely to move from the study area during the study period
* Known exposure to TB cases with known or suspected resistance to isoniazid or rifampicin in the source case
* TB treatment within the past year
* Prior completion of a TPT course without re-exposure to persons with infectious TB since TPT completion
* Receipt of once-daily INH for \>30 days that was given for at least 14 consecutive days in the 30 days prior to enrolment.
* Sensitivity or intolerance to dolutegravir, isoniazid, or rifamycins
* Suspected acute hepatitis or known chronic or unstable liver disease\^; HBsAg positivity or anti-hepatitis A virus (HAV) Immunoglobulin M (IgM) antibody; any infant born to a Hepatitis C positive mother in whom in utero infection in the infant is unknown or under evaluation
* alanine aminotransferase (ALT) \> 3 times the upper limit of normal (ULN)
* Total bilirubin \> 2 .5 times the ULN
* Absolute neutrophil count (ANC) ≤ 750 cells/mm3
* Estimated creatinine clearance \< 60 ml/min (Bedside Schwartz formula)\*
* Pregnancy or breastfeeding (infant of a breastfeeding mother is allowed)
* Women of childbearing potential who are unable or unwilling to use two forms of contraception\*\*
* Weight for age Z score below 2 or severe clinical malnutrition
* On prohibited medications e.g. dofetilide (see Appendix 1)
* Known porphyria
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Months
Maximum Age:
17 Years
Study:
NCT05122767
Study Brief:
Protocol Section:
NCT05122767