Trial reportJournal of acquired immune deficiency syndromes (1999)2014
Raltegravir pharmacokinetics during pregnancy.
Trial report in Journal of acquired immune deficiency syndromes (1999), 2014. 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 40 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
40 citing papers in PubMed, 2 syntheses or guidelines pooled it, 78 citations in OpenAlex.
- Efficacy of raltegravir in achieving virological suppression at delivery in HIV-positive pregnant women: a systematic review and meta-analysis.BMC pregnancy and childbirth · 2025Pooled it
- Pregnancy-Associated Changes in Pharmacokinetics: A Systematic Review.PLoS medicine · 2016Pooled it
- Dolutegravir pharmacokinetics in pregnant and postpartum women living with HIV.AIDS (London, England) · 2018Trial
- Modelling the tail-phase pharmacokinetics of long-acting cabotegravir and rilpivirine from early pregnancy to postpartum at steady state.Journal of pharmacokinetics and pharmacodynamics · 2026Article
- Physiologically-based pharmacokinetic modelling of uridine 5'-diphosphoglucorosultransferase (UGT) substrate drugs in pregnant women.British journal of clinical pharmacology · 2026Article
- From Pharmacovigilance Signals to Mechanistic Phenotypes: Integrating ADMET, PK/PD, and Network Context to Interpret Antiviral Safety in Pregnancy.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Brief Report: Breast Milk Transfer and Infant Exposures to Dolutegravir, Tenofovir, and Tenofovir Alafenamide: Results From IMPAACT 2010/VESTED.Journal of acquired immune deficiency syndromes (1999) · 2026Article
- Maternal HIV Infection and Antiretroviral Therapy in Pregnancy: Implications for Vertical Transmission, Fetal Safety, and Long-Term Infant Outcomes.Pathogens (Basel, Switzerland) · 2025Review
- Pharmacokinetic Adaptations in Pregnancy: Implications for Optimizing Antiretroviral Therapy in HIV-Positive Women.Pharmaceutics · 2025Review
- Physiologically-based pharmacokinetic modelling of long-acting injectable cabotegravir and rilpivirine in pregnancy.British journal of clinical pharmacology · 2025Article
- Mechanisms of altered hepatic drug disposition during pregnancy: small molecules.Expert opinion on drug metabolism & toxicology · 2025Review
- Long-Acting Injectable Cabotegravir and Rilpivirine in a Pregnant Woman With HIV.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024Article
- Care of Pregnant Women Living with Human Immunodeficiency Virus.Clinics in perinatology · 2024Review
- Using PBPK modeling to supplement clinical data and support the safe and effective use of dolutegravir in pregnant and lactating women.CPT: pharmacometrics & systems pharmacology · 2024Article
- A Literature Review of Changes in Phase II Drug-Metabolizing Enzyme and Drug Transporter Expression during Pregnancy.Pharmaceutics · 2023Review
- Relationship between raltegravir trough plasma concentration and virologic response and the impact of therapeutic drug monitoring during pregnancy.International journal of STD & AIDS · 2023Article
- HIV-1 Integrase Strand Transfer Inhibitors and Neurodevelopment.Pharmaceuticals (Basel, Switzerland) · 2022Review
- Physiologically Based Pharmacokinetic Modeling Framework to Predict Neonatal Pharmacokinetics of Transplacentally Acquired Emtricitabine, Dolutegravir, and Raltegravir.Clinical pharmacokinetics · 2021Article
- A population pharmacokinetics analysis assessing the exposure of raltegravir once-daily 1200 mg in pregnant women living with HIV.CPT: pharmacometrics & systems pharmacology · 2021Article
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 9 institutions in 2 countries.
Funding
Abstract
objectiveWe evaluated the pharmacokinetics (PK) of raltegravir in HIV-infected women during pregnancy and postpartum.
methodsInternational Maternal Pediatric Adolescent AIDS Clinical Trials 1026s is an ongoing prospective study of antiretroviral PK during pregnancy (NCT00042289). Women receiving 400 mg raltegravir twice daily in combination antiretroviral therapy had intensive steady-state 12-hour PK profiles performed during pregnancy and at 6- to 12-week postpartum. Targets were trough concentration above 0.035 μg/mL, the estimated 10th percentile in nonpregnant historical controls.
resultsMedian raltegravir area under the curve was 6.6 μg·h/mL for second trimester (n = 16), 5.4 μg·h/mL for third trimester (n = 41), and 11.6 μg·h/mL postpartum (n = 38) (P = 0.03 postpartum vs second trimester, P = 0.001 pp vs third trimester). Trough concentrations were above the target in 69%, 80%, and 79% of second trimester, third trimester, and postpartum subjects, respectively, with wide variability (<0.010-0.917 μg/mL), and no significant difference between third trimester and postpartum trough concentrations was detected. The median ratio of cord blood/maternal raltegravir concentrations was 1.5. HIV RNA levels were <400 copies per milliliter in 92% of women at delivery. Adverse events included elevated liver transaminases in 1 woman and vomiting in 1. All infants with known status are HIV uninfected.
conclusionsMedian raltegravir area under the curve was reduced by approximately 50% during pregnancy; trough concentrations were frequently below target both during late pregnancy and postpartum. Raltegravir readily crossed the placenta. High rates of viral suppression at delivery and the lack of a clear relationship between raltegravir concentration and virologic effect in nonpregnant adults suggest that despite the decreased exposure during pregnancy, a higher dose is not necessary.
Indexed as
Identifiers
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.