NCT05122026Active, not recruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 12 Dec 2025
Brief summary (registry, in English)
Open-label, two-arm, randomized multicenter study to investigate the safety, tolerability, and pharmacokinetics (PK), and potential interactions between dolutegravir (DTG) and rifapentine (RPT) during pregnancy in people with HIV when RPT is given with isoniazid (INH) daily for 4 weeks (1HP) or weekly for 3 months (3HP) as part of tuberculosis (TB) preventive therapy (TPT). Adults (age ≥18) who are pregnant with a singleton pregnancy (confirmed by ultrasound) at a gestational age of 20-34 weeks and virally suppressed on an existing DTG-based plus two nucleoside reverse transcriptase inhibitors (NRTI) antiretroviral (ART) regimen for at least four weeks may participate.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 252 (estimated)
- First submitted
- 26 Oct 2021
- Start date
- 17 Jan 2024
- Primary completion date
- 24 Oct 2025
- Lead sponsor
- The Aurum Institute NPC
- Diseases
- Tuberculosis, HIV
- NCT number
- NCT05122026
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 252
- From 17 Jan 2024 to the primary completion date, 24 Oct 2025
- 3 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
- TB preventive therapy within the last year
- On prohibited medications e.g. dofetilide
Other illness
- Confirmed or suspected TB disease
- Suspected acute hepatitis or known chronic liver disease; HBsAg positivity; severe hepatic impairment
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
- Creatinine clearance \< 50 ml/min
Other
- Likely to move from the study area during the study period
- Known exposure to pulmonary 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 isoniazid or rifamycins
- On nevirapine, etravirine, rilpivirine, PI-based, or raltegravir-containing ART regimens
- Self-reported alcohol use exceeding 21 units per week
- Karnofsky status \< 80
Who the study is looking for
- Age \> 18 years
- Weight \> 50 kg
- Documented HIV infection
- At least 4 weeks of ART and virally suppressed on dolutegravir plus two NRTIs
- Undetectable HIV-1 viral load
- Pregnancy at 20-34 weeks as confirmed by ultrasound
- Singleton pregnancy
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Family Centre for Research with Ubuntu (FAMCRU) Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
| Peri Natal HIV Research Unit - Klerksdorp Tshepong Hospital Coordinator of this site? Confirm its status | Klerksdorp | South Africa | Unknown status |
| The Aurum Institute: Tembisa Clinical Research Centre Coordinator of this site? Confirm its status | Tembisa | South Africa | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.