ArticleHIV medicine2008
Pharmacokinetics of new 625 mg nelfinavir formulation during pregnancy and postpartum.
Article in HIV medicine, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00042289 (Pharmacokinetic Properties of Antiretroviral and Related Drugs During Pregnancy and Postpartum), which is not on this map. Cited by 17 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.
Pharmacokinetic Properties of Antiretroviral and Related Drugs During Pregnancy and Postpartum
Who cites it
17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 24 citations in OpenAlex.
- Pregnancy-Associated Changes in Pharmacokinetics: A Systematic Review.PLoS medicine · 2016Pooled it
- Protecting the fetus against HIV infection: a systematic review of placental transfer of antiretrovirals.Clinical pharmacokinetics · 2014Pooled it
- Pharmacokinetics of Increased Nelfinavir Plasma Concentrations in Women During Pregnancy and Postpartum.Journal of clinical pharmacology · 2019Trial
- Pharmacokinetics of an increased atazanavir dose with and without tenofovir during the third trimester of pregnancy.Journal of acquired immune deficiency syndromes (1999) · 2013Trial
- Steady-state pharmacokinetics, cord blood concentrations, and safety of ritonavir-boosted fosamprenavir in pregnancy.Journal of acquired immune deficiency syndromes (1999) · 2013Trial
- Atazanavir pharmacokinetics with and without tenofovir during pregnancy.Journal of acquired immune deficiency syndromes (1999) · 2011Trial
- Estimation of Fetal-to-Maternal Unbound Steady-State Plasma Concentration Ratio of P-Glycoprotein and/or Breast Cancer Resistance Protein Substrate Drugs Using a Maternal-Fetal Physiologically Based Pharmacokinetic Model.Drug metabolism and disposition: the biological fate of chemicals · 2022Article
- Pharmacokinetics of Once Versus Twice Daily Darunavir in Pregnant HIV-Infected Women.Journal of acquired immune deficiency syndromes (1999) · 2015Article
- Alteration in cytochrome P450 3A4 activity as measured by a urine cortisol assay in HIV-1-infected pregnant women and relationship to antiretroviral pharmacokinetics.HIV medicine · 2015Article
- Basic obstetric pharmacology.Seminars in perinatology · 2014Review
- Obstetric Pharmacokinetic Dosing Studies are Urgently Needed.Frontiers in pediatrics · 2014Review
- Review
- Pharmacokinetic optimization of antiretroviral therapy in pregnancy.Clinical pharmacokinetics · 2012Review
- Prediction and in vitro evaluation of selected protease inhibitor antiviral drugs as inhibitors of carboxylesterase 1: a potential source of drug-drug interactions.Pharmaceutical research · 2012Article
- Selection of HIV resistance associated with antiretroviral therapy initiated due to pregnancy and suspended postpartum.Journal of acquired immune deficiency syndromes (1999) · 2011Article
- Risk factors for detectable HIV-1 RNA at delivery among women receiving highly active antiretroviral therapy in the women and infants transmission study.Journal of acquired immune deficiency syndromes (1999) · 2010Article
- Antiretroviral medications during pregnancy for therapy or prophylaxis.Current HIV/AIDS reports · 2009Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 10 institutions in 3 countries.
Funding
Abstract
objectivesOur objective was to evaluate the pharmacokinetics of nelfinavir (NFV) (625 mg tablets) 1250 mg twice daily during pregnancy and postpartum.
methodsThe participants were HIV-1-infected pregnant women enrolled in P1026s and receiving NFV (625 mg tablets) 1250 mg twice daily as part of routine clinical care. Intensive steady-state 12-h NFV pharmacokinetic profiles were performed during pregnancy and postpartum. The target NFV area under the plasma concentration-time curve (AUC(0-12)) was >or=10th percentile NFV AUC(0-12) in non-pregnant historical controls (18.5 microg h/mL).
resultsOf 27 patients receiving NFV, pharmacokinetic data were available for four (second trimester), 27 (third trimester) and 22 (postpartum) patients. The NFV maximum concentration (C(max)), 12-h post-dose concentration (C(12)) and AUC(0-12) were significantly lower during the third trimester compared to postpartum (P<or=0.03). The metabolite hydroxyl-tert-butylamide (M8) AUC(0-12) and the M8/NFV AUC ratio were lower during the third trimester compared to postpartum (P<0.01). The NFV AUC(0-12) exceeded the AUC(0-12) target for 15/27 (56%) and 21/22 (95%) of third trimester and postpartum patients, respectively. The minimum concentration (C(min)) was above the suggested minimum trough concentration (0.8 mug/mL) in 15% (third trimester) and 18% (postpartum). The plasma viral load was <400 HIV-1 RNA copies/mL in 81% of patients at delivery.
conclusionsThese results suggest that higher doses of NFV should be considered during pregnancy.
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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.