Evidence map›Paper›PMID 16041598›Full record

ArticleEuropean journal of clinical pharmacology2005

Steady-state pharmacokinetics of atazanavir given alone or in combination with saquinavir hard-gel capsules or amprenavir in HIV-1-infected patients.

Elena Seminari, Monica Guffanti, Paola Villani, Nicola Gianotti, Maria Cusato, Giuliana Fusetti, Andrea Galli, Antonella Castagna, Mario Regazzi, Adriano Lazzarin

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In one paragraph

Article in European journal of clinical pharmacology, 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.1field-weighted citation impact, top 24% of its field
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

9 citing papers in PubMed, 12 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Review
  5. Atazanavir: its role in HIV treatment.Expert review of anti-infective therapy · 2008
    Review
  6. Article
  7. Article
  8. Article
  9. Review
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

10 authors at 3 institutions in 2 countries.

Elena SeminariInfectious Disease Department, San Raffaele Scientific Institute, Vita-Salute University, Via Stamira d'Ancona 20, 20122 Milan, Italy.
Monica Guffanti
Paola Villani
Nicola Gianotti
Maria Cusato
Giuliana Fusetti
Andrea Galli
Antonella Castagna
Mario Regazzi
Adriano Lazzarin
University Foundation · BEPoliclinico San Matteo Fondazione · ITIstituti di Ricovero e Cura a Carattere Scientifico · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe aim of this pilot study was to examine the pharmacokinetics of atazanavir (ATV) when given in combination with amprenavir (APV) or saquinavir hard-gel capsules (SQV) to human immunodeficiency virus (HIV)-positive patients.

methodsIncluded in the study were 34 HIV-infected patients enrolled in the ATV Early Access Program, who were treated with unboosted ATV alone (group 1) or with the double protease inhibitor combinations, ATV plus APV (group 2) or ATV plus SQV (group 3). ATV was given at a daily dose of 400 mg q.d. with the morning meal with SQV 1200 mg per day or APV 1200 mg per day. Serial blood samples for steady-state ATV pharmacokinetics were collected before the morning dose and at 1, 2, 3, 6, 8 and 24 h post-dosing. ATV plasma concentrations were measured using a high-performance liquid chromatography method with ultraviolet detection.

resultsOf the patients, 12 received ATV as a single protease inhibitor; 12 received ATV in combination with APV; and 10 in combination with SQV. Geometric mean (coefficient of variation) ATV C(trough) was 110 ng/ml (2.38), 86 ng/ml (0.84) and 149 ng/ml (2.01) in groups 1, 2 and 3, respectively. ATV C(trough) in both double protease inhibitor combination regimens was not significantly different from that as a single protease inhibitor [geometric mean ratio (GMR): 0.77; 95% confidence interval (CI): 0.38-1.58, P=not significant for group 2 versus group 1 and 1.34, 0.40-4.49, P=not significant, for group 3 versus group 1). Patients treated with ATV plus APV had a 40.2% lower ATV C(max) and a 30.8% smaller ATV AUC than the reference group treated with unboosted ATV alone: both these differences were statistically significant (GMR, 95% CI: 0.59, 0.41-0.85, P=0.005 and 0.69, 0.48-0.99, P=0.056, respectively). No difference was observed for either C(max) or AUC between the group treated with ATV plus SQV and the reference group (GMR, 95% CI: 0.78, 0.47-1.30, P=not significant and 1.24, 0.73-2.10, P=not significant, respectively).

conclusionATV pharmacokinetics does not seem to be influenced by the concomitant administration of SQV, whereas APV significantly lowers plasma ATV levels.

Indexed as

AdultAtazanavir SulfateCarbamatesChromatography, High Pressure LiquidDrug Therapy, CombinationFemaleFuransHIV-1HIV InfectionsHIV Protease InhibitorsHumansMaleMiddle AgedOligopeptidesPilot ProjectsPyridinesamprenavirAtazanavir SulfateCarbamatesFuransHIV Protease InhibitorsOligopeptidesPyridinesSaquinavirSulfonamides

Identifiers

PMID16041598
OpenAlexW2086356171

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.