The Influence of Raltegravir on Pravastatin Pharmacokinetics(GRAPPA)

HIV Infections Clinical Trial

— GRAPPA  

Official title:

The Influence of Raltegravir on Pravastatin Pharmacokinetics in Healthy Volunteers (GRAPPA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00665717
• Other study ID #: UMCN-AKF 07.05
• Status: Completed
• Phase: Phase 1
• Start date: May 2008
• Est. completion date: October 2008

Study information

• Verified date: May 2011
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Pravastatin
40 mg tablet; QD; 4 days
• Raltegravir
400mg tablet; BD 4 days
• Pravastatin and raltegravir
pravastatin 40mg tablet QD for 4 days; raltegravir 400mg tablet BD for 4 days

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Centre	Nijmegen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

van Luin M, Colbers A, van Ewijk-Beneken Kolmer EW, Verweij-van Wissen CP, Schouwenberg B, Hoitsma A, da Silva HG, Burger DM. Drug-drug interactions between raltegravir and pravastatin in healthy volunteers. J Acquir Immune Defic Syndr. 2010 Sep;55(1):82- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentrations of pravastatin and raltegravir.		t=0 (predose), 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and (24: for pravastatin only) hours post ingestion on Days 4, 18 and 32. Trough level on Day 2, 16 and 30.
Secondary	To investigate the non-steady state changes in serum low density lipoprotein (LDL) cholesterol secondary to pravastatin use in the presence or absence of raltegravir		Screening and Days 1, 5, 15, 19, 29 and 33.
Secondary	Determination of pharmacokinetic parameters		at each sampling time
Secondary	To evaluate the safety of combined use of pravastatin and raltegravir		entire trial

External Links

•   Publication in Journal of Acquired Immune Deficiency Syndromes; Issue: Volume 55(1), 1 September 2010, pp 82-86