Status:
COMPLETED
TMC278-TiDP6-C136: Effect of TMC278 on Ethinylestradiol and Norethindrone in Healthy Women.
Lead Sponsor:
Tibotec Pharmaceuticals, Ireland
Conditions:
HIV
AIDS
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to investigate the pharmacokinetic interaction between the combination of ethinylestradiol and norethindrone and TMC278 25 mg once daily. Pharmacokinetics means how the dr...
Detailed Description
Human immunodeficiency virus (HIV)-infected patients are routinely being treated with combinations of 3 or 4 drugs (highly active antiretroviral therapy \[HAART\]), to reduce the risk of viral resista...
Eligibility Criteria
Inclusion
- Willing to start or continue oral contraceptive therapy, specifically ethinylestradiol and norethindrone, for the duration of the study
- Consent to a method of birth control in addition to the OC trial medication
- Non-smoking or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 3 months prior to screening
- Body Mass Index (BMI) of 18.0 to 30.0 kg/m2, extremes included
- Healthy on the basis of a physical examination, medical history, electrocardiogram, vital signs and the results of blood biochemistry and hematology tests and a urinalysis carried out at screening.
Exclusion
- The most important eligibility criteria are: Not pregnant or breastfeeding
- Not postmenopausal
- No positive HIV test
- No alcohol or barbiturate, amphetamine, recreational or narcotic drug use
- No hepatitis A, B or C infection
- No currently active gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory or infectious disease
- No history of significant skin disease
- No previously demonstrated clinically significant allergy or hypersensitivity to any of the excipients of the medication administered in this trial (i.e. TMC278, Ovysmen®)
- No clinical significant abnormal finding in the gynaecological examination
- No currently active gynaecological disorders
- No major medical condition that would preclude the safe administration of oral contraceptive therapy
- No participation in an investigational drug trial within 60 days prior to the start of the first OC cycle
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00739622
Start Date
July 1 2008
End Date
December 1 2008
Last Update
April 28 2010
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