Status:
COMPLETED
TMC114-TiDP3-C181: Study to Assess the Pharmacokinetics of Darunavir (DRV) With Different Doses of Ritonavir in Healthy Volunteers.
Lead Sponsor:
Tibotec Pharmaceuticals, Ireland
Conditions:
HIV
AIDS
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The objectives are to determine the effect of different ritonavir doses on darunavir (DRV) oral exposure following once-daily oral dosing of DRV/rtv for 7 days, in order to establish an optimal ritona...
Detailed Description
This is a Phase I, open-label, randomized (study drug assigned by chance), 3-way crossover trial in healthy volunteers to assess the pharmacokinetics of darunavir (DRV), co-administered with different...
Eligibility Criteria
Inclusion
- Healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination, medical history, electrocardiogram (ECG), vital signs, and the results of blood biochemistry, blood coagulation and hematology tests and a urinalysis carried out at screening
Exclusion
- A positive HIV-1 or HIV-2 test at screening
- Hepatitis A, B, or C infection (confirmed by hepatitis A antibody IgM, hepatitis B surface antigen \[with a positive hep B PCR\], or hepatitis C virus antibody, respectively) at Screening
- Any history of significant skin disease such as, but not limited to, rash or eruptions, food or drug allergy, dermatitis, eczema, psoriasis, folliculitis, or urticaria
- Use of concomitant medication, including over-the-counter products, herbal preparations and dietary supplements. Concomitant medication must have been discontinued at least 14 days before the first dose of trial medication except for paracetamol (acetaminophen), hormone replacement therapy and hormonal contraceptives
- Participation in an investigational drug trial within 60 days prior to the first intake of trial medication.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00744887
Start Date
August 1 2008
End Date
December 1 2008
Last Update
June 9 2011
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