Status:
COMPLETED
Interaction Between Etravirine or Darunavir/Ritonavir and Artemether / Lumefantrine
Lead Sponsor:
Janssen Pharmaceutica N.V., Belgium
Conditions:
HIV
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to investigate the pharmacokinetic interaction between etravirine and artemether/lumefantrine and darunavir/ritonavir and artemether/lumefantrine in healthy Human Immunode...
Detailed Description
This is a Phase I, partially randomized, open-label, single-center, two-way, two-period cross-over study to investigate the pharmacokinetic interaction between etravirine (ETR) or darunavir/ritonavir ...
Eligibility Criteria
Inclusion
- if of childbearing potential or if male, use a highly effective method of birth control.
- Able to comply with protocol requirements.
- A BMI (weight in kg divided by the square of height in meters) of 18.5 to 30.0 kg/m2, extremes included.
- healthy on the basis of a medical evaluation
- Non-smoking for at least 3 months prior to selection.
Exclusion
- previously demonstrated clinically significant allergy, hypersensitivity or intolerance to any of the investigational medications or its excipients
- Use of concomitant medication, including over-the-counter products and dietary supplements.
- Having participated in more than 1 study (single or multiple dose) with ETR (TMC125), DRV (TMC114), dapivirine (TMC120) and/or rilpivirine (TMC278, formerly known as R278474), or having developed a rash, erythema or urticaria while participating in a study with the aforementioned compounds.
- A positive pregnancy test or breast feeding at screening or on Day 1.
- Any condition that, in the opinion of the investigator, would compromise the study or the well-being of the patient or prevent the patient from meeting or performing study requirements
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01876966
Start Date
March 1 2011
End Date
July 1 2011
Last Update
June 13 2013
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