The Influence of Raltegravir on Pravastatin Pharmacokinetics(GRAPPA)

Radboud University Medical Center

Status and phase: Completed; Phase 1

Conditions: HIV Infections

Treatments: Drug: Pravastatin and raltegravir; Drug: Raltegravir; Drug: Pravastatin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00665717

UMCN-AKF 07.05

Details and patient eligibility

About

The purpose of this trial is to determine the effect of raltegravir on pravastatin pharmacokinetics and vice versa by intrasubject comparison.

Full description

Pravastatin is a first choice statin for HIV-infected patients. Therefore, raltegravir and pravastatin are expected to be co-administered frequently in HIV-infected patients.Since both agents share the same metabolic pathway, there is a potential for a pharmacokinetic drug-drug interaction.

Because co-administration will be indicated in many HIV-infected patients, it is essential to investigate this potential interaction.

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subject is at least 18 and not older than 55 years of age.
• Subject does not smoke more than 10 cigarettes, 2 cigars, or 2 pipes per day.
• Subject has a Quetelet Index (Body Mass Index) of 18 to 30 kg/m2.
• Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
• Subject is in good age-appropriate health condition.
• Subject has a normal blood pressure and pulse rate.

Exclusion criteria

• Documented history of sensitivity/idiosyncrasy to medicinal products or exci-pients.
• Positive HIV test.
• Positive hepatitis B or C test.
• Pregnant female or breast-feeding female.
• Therapy with any drug.
• Relevant history or presence of pulmonary disorders (especially COPD), car-diovascular disorders, neurological disorders (especially seizures and mi-graine), gastro-intestinal disorders, renal and hepatic disorders, hormonal disorders (especially diabetes mellitus), coagulation disorders.
• Fasting triglyceride levels > 8.0 mmol/L
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

A

Active Comparator group

Description:

Pravastatin 40 mg QD for 4 days

Treatment:

Drug: Pravastatin

B

Active Comparator group

Description:

Raltegravir 400mg BD for 4 days

Treatment:

Drug: Raltegravir

C

Experimental group

Description:

Interaction between pravastatin and raltegravir

Treatment:

Drug: Pravastatin and raltegravir