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Pharmacokinetic Drug Interaction Study Between Raltegravir and Atorvastatin.

Information source: Radboud University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV; Hypercholesterolaemia

Intervention: raltegravir (Drug); Atorvastatin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Radboud University

Official(s) and/or principal investigator(s):
David Burger, Principal Investigator, Affiliation: Radboud University

Summary

Dyslipidemia is highly prevalent among patients with HIV infection and contributes to the increased cardiovascular disease risk in this patient population. Atorvastatin lowers plasma low-density lipoprotein (LDL) cholesterol levels and is used for prevention of artherosclerotic disease. Raltegravir, an HIV integrase inhibitor, could be one of the preferred antiretroviral agents in HIV patients with dyslipidemia because it has a beneficial lipid profile. Theoretically, no clinically relevant drug interaction is expected between atorvastatin and raltegravir. However, atorvastatin and raltegravir share similar metabolic pathways which could be relevant in the occurrence of pharmacokinetic interactions. In order to be able to recommend raltegravir and atorvastatin concomitant use, a pharmacokinetic study in healthy volunteers is proposed.

Clinical Details

Official title: Pharmacokinetic Drug Interaction Study Between Raltegravir and Atorvastatin (AVIATOR).

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome: raltegravir AUC and atorvastatin AUC

Secondary outcome:

adverse events

serum LDL cholesterol

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 at screening.

- 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. Results of biochemistry, haematology and urinalysis testing should be within the laboratory's reference ranges. If laboratory results are not within the reference ranges, the subject is included on condition that the Investigator judges that the deviations are not clinically relevant. This should be clearly recorded.

- 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 day

1) or breast-feeding female. Female subjects of childbearing potential without adequate contraception, e. g. hysterectomy, bilateral tubal ligation, (non-hormonal) intrauterine device, total abstinence, double barrier methods, or two years post-menopausal. They must agree to take precautions in order to prevent a pregnancy throughout the entire conduct of the study.

- Therapy with any drug (for two weeks preceding dosing), except for acetaminophen.

- Relevant history or presence of pulmonary disorders (especially COPD), cardiovascular

disorders, neurological disorders (especially seizures and migraine), psychiatric disorders, gastro-intestinal disorders, renal and hepatic disorders, hormonal disorders (especially diabetes mellitus), coagulation disorders, musculoskeletal and connective tissue 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 study and the procedures

required.

- Participation in a drug study 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

CRCN Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands
Additional Information

published results AVIATOR trial

Starting date: March 2013
Last updated: June 12, 2015

Page last updated: August 23, 2015

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