Rifapentine and Isoniazid TB Preventive Therapy (3HP) for Children Taking Dolutegravir-based Antiretroviral Treatment (DOLPHIN KIDS)

Launched by THE AURUM INSTITUTE NPC · Nov 4, 2021

Keywords

ClinConnect Summary

The DOLPHIN KIDS clinical trial is studying a combination of two medications, Rifapentine and Isoniazid, to prevent tuberculosis (TB) in children and teenagers living with HIV who are receiving a specific type of HIV treatment called dolutegravir-based therapy. The trial aims to see if this preventive treatment is safe and effective for young patients aged 3 months to 17 years who have an undetectable level of the HIV virus in their blood. To qualify, participants must weigh more than 3 kilograms and cannot have active TB or certain health conditions.

If eligible, participants will receive the TB preventive treatment weekly for 12 weeks, starting four weeks after they begin their dolutegravir HIV treatment. The trial is currently recruiting participants and welcomes children of all genders. It’s important to note that those with recent TB treatment or certain health issues, such as liver disease or specific allergies, will not be able to join the study. Families interested in this trial should discuss it with their healthcare provider to understand more about the benefits and responsibilities involved.

Gender

ALL

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