Status:
COMPLETED
Impact of Menstrual Cycle on Antiretroviral Pharmacokinetics in Healthy Women
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Healthy
Eligibility:
FEMALE
21-40 years
Phase:
PHASE4
Brief Summary
Data suggest that women taking drugs to treat human immunodeficiency virus (HIV) have higher amounts of drugs in their body compared with men taking the same dose of anti-HIV drugs. The reason for thi...
Eligibility Criteria
Inclusion
- Healthy, HIV negative, nonsmoking females between 21 and 40 years of age.
- Subjects must be within 20% of their ideal body weight and have a regular menstrual cycle, defined as at least 10 cycles per year occurring approximately every 28 ± 4 days and cycle length varying by not more than 7 days.
- Subjects must be willing and able to provide written informed consent.
- Subjects cannot be breast feeding, pregnant or be taking hormonal contraception within 3 months prior to study enrollment. However, they must agree to use an effective non-hormonal method of contraception during the study.
Exclusion
- Subjects receiving prescription or over-the-counter products which may interact with the study medication will be excluded from the study.
- Subjects with a Grade 3 or higher laboratory liver, renal or hematology abnormality as specified below in accordance with the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table) Version 1.0, Dec 2004, will be excluded.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00869960
Start Date
March 1 2009
End Date
December 1 2010
Last Update
September 6 2013
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294