Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2022
Pharmacokinetics and Safety of 3 Months of Weekly Rifapentine and Isoniazid for Tuberculosis Prevention in Pregnant Women.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02651259 (A Phase I/II Trial of the Pharmacokinetics, Tolerability, and Safety of Once-Weekly Rifapentine and Isoniazid in HIV-1-infected and HIV-1-uninfected Pregnant and Postpartum Women With Latent Tuberculosis Infection), which is not on this map. Cited by 26 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase I/II Trial of the Pharmacokinetics, Tolerability, and Safety of Once-Weekly Rifapentine and Isoniazid in HIV-1-infected and HIV-1-uninfected Pregnant and Postpartum Women With Latent Tuberculosis Infection
Who cites it
26 citing papers in PubMed, 2 syntheses or guidelines pooled it, 31 citations in OpenAlex.
- The Pharmacokinetics and Target Attainment of Antimicrobial Drugs Throughout Pregnancy: Part III Non-penicillin and Non-cephalosporin Drugs.Clinical pharmacokinetics · 2023Pooled it
- Safety Evaluation of Antituberculosis Drugs During Pregnancy: A Systematic Review and Meta-Analysis.Frontiers in surgery · 2022Pooled it
- Pregnancy Outcomes after Exposure to Tuberculosis Treatment in Phase 3 Clinical Trial, 2016-2020.Emerging infectious diseases · 2025Trial
- High Isoniazid Exposures When Administered with Rifapentine Once Weekly for Latent Tuberculosis in Individuals with Human Immunodeficiency Virus.Antimicrobial agents and chemotherapy · 2023Trial
- Safety of Short-course Weekly Rifapentine and Isoniazid (3HP) for TB Preventive Treatment at Conception and During First Trimester in Women With HIV: A Secondary Analysis of the WHIP3TB trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026Article
- Article
- Rifampin Exposure in Pregnant and Nonpregnant Women With Tuberculosis in India.The Journal of infectious diseases · 2026Article
- Tuberculosis Prevention in Pregnant Women Living with HIV: A Review of the Current Management Strategies and Guidance.Infection and drug resistance · 2026Review
- Tuberculosis screening and care delivery in pregnant and postpartum persons living with HIV in Botswana.PLOS global public health · 2026Article
- Advancing the inclusion of pregnant and lactating populations in HIV PrEP research: ethical, regulatory, and surveillance recommendations from a multisectoral working group.Frontiers in public health · 2026Article
- Tuberculosis Preventive Treatment for Pregnant People With HIV in South Africa: A Modeling Analysis of Clinical Benefits and Risks.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Article
- An Update on the Clinical Management of HIV and Tuberculosis Co-Infection in Pregnancy: TB Preventative Therapy, Long-Acting ARVs, and Bedaquiline-Based Regimens.Current HIV/AIDS reports · 2025Review
- A review of antibiotic safety in pregnancy-2025 update.Pharmacotherapy · 2025Review
- Mechanisms of altered hepatic drug disposition during pregnancy: small molecules.Expert opinion on drug metabolism & toxicology · 2025Review
- TB prevalence among pregnant women with HIV in Rio de Janeiro, Brazil.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2024Article
- Mycobacterium tuberculosis infection in pregnancy: A systematic review.PLOS global public health · 2024Article
- Review
- The effect of antenatal isoniazid preventive therapy on birth outcomes in Western Kenya.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2023Article
- Application of a physiologically based pharmacokinetic model to predict isoniazid disposition during pregnancy.Clinical and translational science · 2023Article
- Updated considerations in the diagnosis and management of tuberculosis infection and disease: integrating the latest evidence-based strategies.Expert review of anti-infective therapy · 2023Review
Corrections and comments
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Authors and funding
20 authors at 14 institutions in 8 countries.
Funding
Abstract
backgroundPregnancy increases the risk of tuberculosis and its complications. A 3-month regimen of weekly isoniazid and rifapentine (3HP) is safe and effective for tuberculosis prevention in adults and children, including those with HIV, but 3HP has not been evaluated in pregnancy.
methodsIMPAACT 2001 was a phase I/II trial evaluating the pharmacokinetics and safety of 3HP among pregnant women with indications for tuberculosis preventative therapy in Haiti, Kenya, Malawi, Thailand, and Zimbabwe (NCT02651259). Isoniazid and rifapentine were provided at standard doses (900 mg/week). Pharmacokinetic sampling was performed with the first (second/third trimester) and twelfth (third trimester/postpartum) doses. Nonlinear mixed-effects models were used to estimate drug population pharmacokinetics.
resultsOf 50 participants, 20 had HIV and were taking efavirenz-based antiretroviral therapy. Among women without HIV, clearance of rifapentine was 28% lower during pregnancy than postpartum (1.20 vs 1.53 L/hour, P < .001), with area under the concentration-time curve (AUCSS) of 786 and 673 mg × hour/L, respectively. In pregnant women with HIV, clearance was 30% higher than women without HIV (P < .001), resulting in lower AUCss (522 mg × hour/L); clearance did not change significantly between pregnancy and postpartum. Pregnancy did not impact isoniazid pharmacokinetics. There were no drug-related serious adverse events, treatment discontinuations, or tuberculosis cases in women or infants.
conclusions3HP does not require dose adjustment in pregnancy. Rifapentine clearance is higher among women with HIV, but all women achieved exposures of rifapentine and isoniazid associated with successful tuberculosis prevention. The data support proceeding with larger safety-focused studies of 3HP in pregnancy. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov, NCT02651259.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.