ArticleBritish journal of clinical pharmacology2013
Reduced indinavir exposure during pregnancy.
Article in British journal of clinical pharmacology, 2013. 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 13 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
13 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- 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 Rilpivirine in HIV-Infected Pregnant Women.Journal of acquired immune deficiency syndromes (1999) · 2016Trial
- Regulation of Human Renal Transporters by Pregnancy-Related Hormones in Primary Proximal Tubular Epithelial Cells.Metabolites · 2026Article
- Mechanisms of altered hepatic drug disposition during pregnancy: small molecules.Expert opinion on drug metabolism & toxicology · 2025Review
- Pharmacokinetic Enhancement of HIV Antiretroviral Therapy During Pregnancy.Journal of clinical pharmacology · 2020Review
- Drug-Drug Interactions with Antiretroviral Drugs in Pregnant Women Living with HIV: Are They Different from Non-Pregnant Individuals?Clinical pharmacokinetics · 2020Review
- Drug dosing during pregnancy-opportunities for physiologically based pharmacokinetic models.Journal of pharmacokinetics and pharmacodynamics · 2020Review
- Placental transfer and safety in pregnancy of medications under investigation to treat coronavirus disease 2019.American journal of obstetrics & gynecology MFM · 2020Review
- Pharmacokinetics of Once Versus Twice Daily Darunavir in Pregnant HIV-Infected Women.Journal of acquired immune deficiency syndromes (1999) · 2015Article
- Prediction of gestational age-dependent induction of in vivo hepatic CYP3A activity based on HepaRG cells and human hepatocytes.Drug metabolism and disposition: the biological fate of chemicals · 2015Article
- Basic obstetric pharmacology.Seminars in perinatology · 2014Review
- Expansion of a PBPK model to predict disposition in pregnant women of drugs cleared via multiple CYP enzymes, including CYP2B6, CYP2C9 and CYP2C19.British journal of clinical pharmacology · 2014Article
Corrections and comments
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Authors and funding
16 authors.
Funding
Abstract
aimTo describe the pharmacokinetics and safety of indinavir boosted with ritonavir (IDV/r) during the second and third trimesters of pregnancy and in the post-partum period.
methodsIMPAACT P1026s is an on-going, prospective, non-blinded study of antiretroviral pharmacokinetics (PK) in HIV-infected pregnant women with a Thai cohort receiving IDV/r 400/100 mg twice daily during pregnancy through to 6-12 weeks post-partum as part of clinical care. Steady-state PK profiles were performed during the second (optional) and third trimesters and at 6-12 weeks post-partum. PK targets were the estimated 10(th) percentile IDV AUC (12.9 μg ml(-1)h) in non-pregnant historical Thai adults and a trough concentration of 0.1 μg ml(-1), the suggested minimum target.
resultsTwenty-six pregnant women were enrolled; thirteen entered during the second trimester. Median (range) age was 29.8 (18.9-40.8) years and weight 60.5 (50.0-85.0) kg at the third trimester PK visit. The 90% confidence limits for the geometric mean ratio of the indinavir AUC(0,12 h) and Cmax during the second trimester and post-partum (ante : post ratios) were 0.58 (0.49, 0.68) and 0.73 (0.59, 0.91), respectively; third trimester/post-partum AUC(0,12 h) and Cmax ratios were 0.60 (0.53, 0.68) and 0.63 (0.55, 0.72), respectively. IDV/r was well tolerated and 21/26 women had a HIV-1 viral load < 40 copies ml(-1) at delivery. All 26 infants were confirmed HIV negative.
conclusionIndinavir exposure during the second and third trimesters was significantly reduced compared with post-partum and ∼30% of women failed to achieve a target trough concentration. Increasing the dose of IDV/r during pregnancy to 600/100 mg twice daily may be preferable to ensure adequate drug concentrations.
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