NCT05122767Active, not recruitingPhase 1/2
Rifapentine and Isoniazid TB Preventive Therapy (3HP) for Children Taking Dolutegravir-based Antiretroviral Treatment (DOLPHIN KIDS)
Safety, Tolerability and Drug-drug Interactions of Short-course Treatment of Latent Tuberculosis Infection With High-dose Once-weekly Rifapentine and Isoniazid (3HP) Among Infants, Children and Adolescents Living With HIV Taking Dolutegravir-based Antiretroviral Treatment
Source: ClinicalTrials.gov · Last updated 12 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 92 (estimated)
- First submitted
- 9 Aug 2021
- Start date
- 24 May 2023
- Primary completion date
- 4 Jul 2025
- Lead sponsor
- The Aurum Institute NPC
- Diseases
- Tuberculosis, HIV
- NCT number
- NCT05122767
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 92
- From 24 May 2023 to the primary completion date, 4 Jul 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- 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.
- On prohibited medications e.g. dofetilide (see Appendix 1)
Other illness
- 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
Lab values
- 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)\*
Age
- Weight for age Z score below 2 or severe clinical malnutrition
Other
- 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
- Sensitivity or intolerance to dolutegravir, isoniazid, or rifamycins
- 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\*\*
- Known porphyria
Who the study is looking for
- 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
Age in the registry: 3 months to 17 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peri Natal HIV Research Unit - Klerksdorp Tshepong Hospital Coordinator of this site? Confirm its status | Klerksdorp | South Africa | Unknown status |
| The Aurum Institute: Pretoria Clinical Research Centre Coordinator of this site? Confirm its status | Pretoria | South Africa | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.