Effect of a Single Supratherapeutic Dose of Dolutegravir on Cardiac Repolarization

Shuguang Chen; Sherene Min; Amanda Peppercorn; Julie Borland; Yu Lou; Ivy Song; Tamio Fujiwara; Stephen C. Piscitelli

doi:10.1002/j.1875-9114.2012.01033.x

March 15, 2012Pharmacotherapy The Journal of Human Pharmacology and Drug Therapy

Effect of a Single Supratherapeutic Dose of Dolutegravir on Cardiac Repolarization

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Why the study?

Does a single supratherapeutic dose of dolutegravir prolong the QTc interval in healthy subjects?

Structured PICO

Does a single supratherapeutic dose of dolutegravir prolong the QTc interval in healthy subjects?

P

Population

42 healthy subjects

I

Intervention

Single dose of dolutegravir 250-mg suspension

C

Comparator

Single dose of placebo suspension and single dose of moxifloxacin 400-mg tablet (open-label positive control) in a 3-period crossover design separated by 14-day washout periods

O

Outcome

Placebo-adjusted mean change from baseline of the QTc interval (ΔΔQTcF) using Fridericia's formulasurrogate

A supratherapeutic dose of dolutegravir does not prolong the QTc interval or affect cardiac repolarization in healthy subjects.

Implication

Supports dolutegravir use without QTc monitoring; confirms cardiac safety in this thorough QT study.

Discussion

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Cite This Study

Chen et al. (2012) studied this question.

synapsesocial.com/papers/6a853e26895c7e29f4c6b6cb https://doi.org/10.1002/j.1875-9114.2012.01033.x

View Full Paper

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Effect of a Single Supratherapeutic Dose of Dolutegravir on Cardiac Repolarization

Structured PICO

Implication

Discussion

Cite This Study

Effect of a Single Supratherapeutic Dose of Dolutegravir on Cardiac Repolarization

Structured PICO

Implication

Discussion

Cite This Study

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