Evidence map›Paper›PMID 16934047›Full record

ArticleBritish journal of clinical pharmacology2006

Pharmacokinetics of nelfinavir in HIV-1-infected pregnant and nonpregnant women.

P Villani, M Floridia, M F Pirillo, M Cusato, E Tamburrini, A F Cavaliere, G Guaraldi, C Vanzini, A Molinari, A degli Antoni and 1 more

Abstract readComparative Study
In one paragraph

Article in British journal of clinical pharmacology, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Atazanavir pharmacokinetics with and without tenofovir during pregnancy.Journal of acquired immune deficiency syndromes (1999) · 2011
    Trial
  6. Biological sex differences in pharmacokinetics and adverse drug reactions.Naunyn-Schmiedeberg's archives of pharmacology · 2026
    Review
  7. Pharmacokinetics of drugs in pregnancy.Seminars in perinatology · 2015
    Review
  8. Article
  9. Review
  10. Review
  11. Pharmacokinetics of tacrolimus during pregnancy.Therapeutic drug monitoring · 2012
    Article
  12. Review
  13. Article
  14. Clinical therapeutics in pregnancy.Journal of biomedicine & biotechnology · 2011
    Article
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  16. Article
  17. Article
  18. Article
  19. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

P VillaniDepartment of Pharmacology, IRCCS Policlinico S. Matteo, Pavia, Italy.
M Floridia
M F Pirillo
M Cusato
E Tamburrini
A F Cavaliere
G Guaraldi
C Vanzini
A Molinari
A degli Antoni
M Regazzi

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo compare steady-state nelfinavir (NFV) pharmacokinetics in pregnant and nonpregnant HIV-infected women.

methodsTwenty-five pregnant HIV-infected women were selected from an ongoing observational study evaluating the pharmacokinetics of antiretroviral agents during pregnancy. Twenty of them were in the third and five in the second trimester. Data for the control group of 21 HIV-infected nonpregnant women were taken from a previous multicentre pharmacokinetic trial. All the participating women achieved steady-state plasma concentrations while on a highly active antiretroviral therapy (HAART) regimen including NFV (1250 mg bid) and two nucleoside reverse transcriptase inhibitors (NRTIs). Blood samples for NFV measurement were collected predose (C(trough)) and at 0.5, 1, 2, 3, 4, 5, 6, 8 and 12 h post dose.

resultsDuring the third trimester of pregnancy NFV AUC(0-12 h) median (range) values were 25.76 (12.61-42.74) microg h(-1) ml(-1), and were 32.49 (19.16-63.81) microg h(-1) ml(-1) in the control group [mean difference - 9.30 microg h(-1) ml(-1); 95% confidence interval (CI) -15.76, -2.83; P < 0.05). Median oral clearance (CL/F) was significantly higher in pregnant women than in the control group (48.5 l h(-1), range 29.3-99.1 l h(-1) vs. 38.5 l h(-1), range 19.6-65.2 l h(-1); mean difference 12.6 l h(-1); 95% CI 3.3, 21.9) but the difference disappeared when CL/F was adjusted for body weight. C(trough) was significantly (P < 0.01) lower in pregnant compared with nonpregnant women (median 0.8 microg ml(-1), range 0-2.6 microg ml(-1) vs. 1.5 microg ml(-1), range 0.5-4.9 microg ml(-1); mean difference -1.0 microg ml(-1); 95% CI -1.7, -0.31). The median elimination half-life of NFV observed during pregnancy was 3.7 h (range 1.4-6.6 h), compared with 5.2 (range 3.1-10.1 h) in the control group (mean difference -1.7; 95% CI -2.8, -0.51).

conclusionsOur results indicate that women in the later stages of pregnancy may be exposed to subtherapeutic concentrations of NFV. Thus, adjustments in drug dosage or frequency of administration may be required.

Indexed as

HIV-1FemaleHIV InfectionsHIV Protease InhibitorsHumansNelfinavirPregnancyPregnancy Complications, InfectiousPregnancy Trimester, ThirdHIV Protease InhibitorsNelfinavir

Identifiers

PMID16934047
PMCPMC1885131

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Registered trials

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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.