Impact of Menstrual Cycle on Antiretroviral Pharmacokinetics in Healthy Women
Condition: Healthy
Intervention: tenofovir; emtricitabine; atazanavir; ritonavir
Intervention description: tenofovir 300 mg one dose on 2 separate visits: within 5 days after Day 1 of Follicular phase and then within a 4 day window of the leutal phase (day 14 of the menstrual cycle); emtricitabine 200 mg on 2 separate visits: within 5 days after Day 1 of Follicular phase and then within a 4 day window of the leutal phase (day 14 of the menstrual cycle).; atazanavir 300mg one dose on 2 separate visits: within 5 days after Day 1 of Follicular phase and then within a 4 day window of the leutal phase (day 14 of the menstrual cycle).; ritonavir 100 mg one dose on 2 separate visits: within 5 days after Day 1 of Follicular phase and then within a 4 day window of the leutal phase (day 14 of the menstrual cycle).
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate; Tenofovir; Emtricitabine
Phase: Phase 4
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: Female
Minimum age: 21 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy Volunteers

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 this higher drug exposure has not been determined. The primary purpose of this
      study is to examine whether the pharmacokinetics (factors that determine the amount of drug
      in the body) of anti-HIV drugs change during different phases of the menstrual cycle in women
      and ultimately result in higher amounts of drug in the body compared with men. In other
      words, we plan to examine whether changes in sex hormones throughout the menstrual cycle
      affect the amount of anti-HIV drugs in women. The antiretroviral drugs atazanavir, ritonavir,
      tenofovir and emtricitabine will be studied. This study will be conducted in healthy women
      since HIV may change the pharmacokinetics of anti-HIV drugs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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.