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

NCT05122767

Active Not RecruitingPhase 1, Phase 2

Sponsor: The Aurum Institute NPC

Conditions: Tuberculosis, HIV

Interventions: Dolutegravir, 3HP

Countries: South Africa

Single-arm, multi-center, Phase I/II clinical trial, in two groups. Individuals with HIV infection taking Efavirenz (EFV), nevirapine (NVP) or lopinavir/ritonavir (LPV/r) and two nucleoside reverse transcriptase inhibitors (NRTI) who have undetectable HIV viral load (VL) (\< 50 copies/mL) and an indication for tuberculosis (TB) preventive treatment (TPT), will be switched to dolutegravir (DTG) with tenofovir/emtricitabine (TDF/FTC), tenofovir/lamivudine (TDF/3TC), abacavir/lamivudine (ABC/3TC) or zidovudine/lamivudine (AZT/3TC) in accordance with South African National HIV Guidelines. Groups 1 and 2 will receive weekly HP for 12 total doses starting 4 weeks after initiating DTG. Individuals who are on an existing DTG-based plus two NRTI antiretroviral therapy (ART) regimen for at least four weeks (and have not received efavirenz, or nevirapine or lopinavir/ritonavir for at least four weeks) who have an undetectable HIV viral load may also participate.

Eligibility overview

Sex: ALL

Age: 3 Months to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (2)

Pretoria, Gauteng, South Africa
Klerksdorp, North West, South Africa