Status:
COMPLETED
The Influence of Raltegravir on Pravastatin Pharmacokinetics(GRAPPA)
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
HIV Infections
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this trial is to determine the effect of raltegravir on pravastatin pharmacokinetics and vice versa by intrasubject comparison.
Detailed 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 th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00665717
Start Date
May 1 2008
End Date
October 1 2008
Last Update
October 19 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands