Safety and Tolerability of 1 Month Daily (1HP) and 3 Months Weekly (3HP) Isoniazid and Rifapentine With Pharmacokinetics of Dolutegravir (DTG) in Pregnant People With HIV

Launched by THE AURUM INSTITUTE NPC · Nov 4, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and tolerability of two different treatment schedules using the medications isoniazid and rifapentine in pregnant individuals with HIV. The study aims to understand how these medications work together during pregnancy and whether they are safe for both the mother and the baby. Participants will either take isoniazid daily for one month or rifapentine weekly for three months, all while continuing their HIV treatment with another medication called dolutegravir.

To be eligible for this trial, participants need to be over 18 years old, weigh more than 50 kg, and have been on HIV treatment for at least four weeks with a stable viral load. They also need to be pregnant with a single baby, confirmed by an ultrasound, and between 20 to 34 weeks of pregnancy. Participants can expect close monitoring during the study to ensure their health and that of their baby. It’s important to note that those with certain health conditions or recent TB treatment are not eligible to participate. This research is crucial for ensuring safe treatment options for pregnant individuals living with HIV and at risk for tuberculosis.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Age \> 18 years
• • 2. Weight \> 50 kg
• • 3. Documented HIV infection
• • 4. At least 4 weeks of ART and virally suppressed on dolutegravir plus two NRTIs
• • 5. Undetectable HIV-1 viral load
• • 6. Pregnancy at 20-34 weeks as confirmed by ultrasound
• • 7. Singleton pregnancy
• Exclusion Criteria:
• • 1. Confirmed or suspected TB disease
• • 2. Likely to move from the study area during the study period
• • 3. Known exposure to pulmonary TB cases with known or suspected resistance to isoniazid or rifampicin in the source case
• • 4. TB treatment within the past year
• • 5. TB preventive therapy within the last year
• • 6. Sensitivity or intolerance to isoniazid or rifamycins
• • 7. On nevirapine, etravirine, rilpivirine, PI-based, or raltegravir-containing ART regimens
• • 8. Suspected acute hepatitis or known chronic liver disease; HBsAg positivity; severe hepatic impairment
• • 9. Alanine aminotransferase (ALT) ≥ 3 times the upper limit of normal (ULN)
• • 10. Total bilirubin ≥ 2.5 times the ULN
• • 11. Absolute neutrophil count (ANC) \< 750 cells/mm3
• • 12. Creatinine clearance \< 50 ml/min
• • 13. Self-reported alcohol use exceeding 21 units per week
• • 14. Karnofsky status \< 80
• • 15. On prohibited medications e.g. dofetilide