Status:
COMPLETED
Pharmacokinetic Study on Raltegravir and Lamotrigine
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
HIV Infection
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine whether interactions between raltegravir and lamotrigine take place and to study the safety of the combination raltegravir/lamotrigine before used in HIV pati...
Detailed Description
Lamotrigine is an anticonvulsive drug that is used both for the treatment of HIV-associated neuropathic pain and the treatment of epilepsy in HIV-infected individuals. Lamotrigine is metabolized via g...
Eligibility Criteria
Inclusion
- Between 18 and 55 years of age
- Subject does not smoke more than 10 cigarettes, 2 cigars or 2 pipes per day
- Subject has a Quetelet Index of 18 to 30 kg/m2
- Subject is able and willing to sign informed consent
- Subject is in good age-appropriate health condition
- Subject has a normal blood pressure and pulse rate
Exclusion
- History of sensitivity/idiosyncrasy to medicinal products or excipients
- Positive HIV test
- Positive hepatitis B or C test
- Therapy with any drug (2 weeks preceding dosing) except for paracetamol
- Relevant history or presence of pulmonary disorders, cardiovascular
- History of or current abuse of drugs, alcohol or solvents
- Inability to understand the nature and extent of the trial and procedures
- 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 :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00618241
Start Date
February 1 2008
End Date
October 1 2008
Last Update
October 19 2020
Active Locations (1)
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1
Radboud University Medical Center
Nijmegen, Gelderland, Netherlands