Pharmacokinetic Study of Posaconazole Boosted Fosamprenavir
Information source: Radboud University
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infection; Fungal Infection
Intervention: Posaconazole (Drug); Fosamprenavir (Drug); Ritonavir (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Radboud University Official(s) and/or principal investigator(s):
David M Burger, PharmD PhD, Principal Investigator, Affiliation: Radboud University
Overall contact:
David M Burger, PharmD PhD, Phone: ++31 24 3616405, Email: d.burger@akf.umcn.nl
Summary
The purpose of this study is to determine the influence of posaconazole on unboosted
fosamprenavir pharmacokinetics, and vice versa, in healthy volunteers. A second objective is
to determine the safety of combined use of fosamprenavir with posaconazole in healthy
volunteers.
Clinical Details
Official title: Pharmacokinetic Study of Posaconazole Boosted Fosamprenavir
Study design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study
Primary outcome: Plasma concentrations of amprenavir and posaconazole
Secondary outcome: Adverse events (safety) due to concomitant use of fosamprenavir and posaconazole
Detailed description:
Infections with fungi and yeast frequently occur in patients infected with the human
immunodeficiency virus type 1 (HIV-1).
Fosamprenavir is a PI that is used to treat HIV-infection in combination with ritonavir. Once
hydrolyzed to amprenavir, this substance is a substrate for CYP3A4. Ritonavir is an extremely
potent inhibitor of CYP3A4 and serves as a booster of the pharmacokinetics of amprenavir.
Posaconazole is a very potent CYP3A4 inhibitor and therefore might enhance amprenavir
pharmacokinetics in a similar way as ritonavir.
The current study is designed to test this hypothesis. When there is an indication for
antifungal therapy in an HIV-infected patient, temporal replacement of ritonavir by
posaconazole would be an attractive option for combined treatment of HIV and fungal
infection.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subject is at least 18 and not older than 55 years of age on the day of the first
dosing.
- Subject does not smoke more than 10 cigarettes, 2 cigars, or 2 pipes per day for at
least 3 months prior to the first dosing.
- Subject has a Quetelet Index (Body Mass Index) of 18 to 30 kg/m2, extremes included.
- Subject is able and willing to sign the Informed Consent Form prior to screening
evaluations.
- Subject is in good age-appropriate health condition as established by medical history,
physical examination, electrocardiography, results of biochemistry, haematology and
urinalysis testing within 4 weeks prior to the first dose.
- Subject has a normal blood pressure and pulse rate, according to the Investigator's
judgement.
Exclusion Criteria:
- Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
- Positive HIV test.
- Positive hepatitis B or C test.
- Pregnant female (as confirmed by an HCG test performed less than 4 weeks before the
first dose) or breast-feeding female.
- Therapy with any drug (for two weeks preceding dosing), except for paracetamol.
- Subjects with an ECG with QTc interval greater than 450 ms for men, and greater than
470 ms for women at screening.
- Relevant history or presence of pulmonary disorders (especially COPD), cardiovascular
disorders, neurological disorders (especially seizures and migraine),
gastro-intestinal disorders, renal and hepatic disorders, hormonal disorders
(especially diabetes mellitus), coagulation disorders.
- Relevant history or current condition that might interfere with drug absorption,
distribution, metabolism or excretion.
- History of or current abuse of drugs, alcohol or solvents.
- Inability to understand the nature and extent of the trial and the procedures
required.
- Participation in a drug trial within 60 days prior to the first dose.
- Donation of blood within 60 days prior to the first dose.
- Febrile illness within 3 days before the first dose
Locations and Contacts
David M Burger, PharmD PhD, Phone: ++31 24 3616405, Email: d.burger@akf.umcn.nl
Radboud University Nijmegen Medical Centre, Nijmegen, Gelderland, Netherlands; Recruiting
David M Burger, PharmD PhD, Phone: ++31 24 3616405, Email: d.burger@akf.umcn.nl
David M Burger, PharmD PhD, Principal Investigator
Additional Information
Starting date: January 2009
Ending date: July 2009
Last updated: January 19, 2009
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