Pharmacokinetic Study on Raltegravir and Lamotrigine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-10-31

Brief Summary

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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 patients.

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Detailed Description

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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 glucuronidation.

Raltegravir is a newly developed integrase inhibitor that is also metabolized via glucuronidation.

Since both agents are metabolized via glucuronidation, there is a possibility of competition for glucuronidation, leading to drug-drug interactions between raltegravir and lamotrigine.

This primary objective of this study is to determine the effect of raltegravir on the pharmacokinetics of single dose lamotrigine (by intrasubject comparison). A secondary objective is to determine the effect of single dose lamotrigine on the pharmacokinetics of raltegravir when compared to historical controls. Another secondary objective is to evaluate the safety of combined use of single dose lamotrigine and raltegravir.

Conditions

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HIV Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group A: day 1-5 Raltegravir 400 mg oral BD (twice daily). Lamotrigine one oral dose 100 mg on day 4. Wash-out 6-31. Followed by one oral dose Lamotrigine 100 mg on day 34.

5 days Raltegravir 400 mg oral BD. Lamotrigine one oral dose 100mg on day 34.

Group Type EXPERIMENTAL

lamotrigine

Intervention Type DRUG

100 mg

Raltegravir

Intervention Type DRUG

400 mg BD

B

Group B: day 4 Lamotrigine one oral dose on day 4. Wash-out day 6-28 followed by Raltegravir 400 mg oral BD day 29-33. One dose Lamotrigine 100 mg oral on day 32.

One dose Lamotrigine 100 mg oral.

Group Type ACTIVE_COMPARATOR

lamotrigine

Intervention Type DRUG

100 mg

Raltegravir

Intervention Type DRUG

400 mg BD

Interventions

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lamotrigine

100 mg

Intervention Type DRUG

Raltegravir

400 mg BD

Intervention Type DRUG

Other Intervention Names

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Lamictal

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes