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Impact of Menstrual Cycle on Antiretroviral Pharmacokinetics in HIV-Infected Women

This study has been withdrawn prior to enrollment.
(Lack of enrollment)
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Jennifer King, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01394133
First received: July 12, 2011
Last updated: April 29, 2013
Last verified: April 2013
History of Changes
  Purpose

Data suggests 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 yet been determined. The primary purpose of this study is to examine whether a 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 HIV infected women. The antiretroviral drugs atazanavir, ritonavir, tenofovir and emtricitabine will be studied.


Condition Intervention
HIV Infected
 Drug: Tenofovir, Emtricitabine, Atazanavir, Ritonavir

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Menstrual Cycle on Antiretroviral Pharmacokinetics in HIV-Infected Women

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • PK parameters [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    The area under the concentration time curve and minimum concentration for tenofovir, emtricitabine, atazanavir and ritonavir


Biospecimen Retention:   Samples Without DNA

5 mL of plasma
Enrollment: 0
Study Start Date: July 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
HIV+ Female
HIV infected women between 21-40 years of age, not receiving oral contraceptives.
 Drug: Tenofovir, Emtricitabine, Atazanavir, Ritonavir
Women will be receiving Tenofovir 300mg, Emtricitabine 200mg, Atazanavir 300mg, Ritonavir 100mg, one dose on 2 separate visits. These medications will not be prescribed from the physician and not provided by the study.

  Eligibility
Ages Eligible for Study:   21 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

HIV-infected women will be selected from the primary care office

Criteria

Inclusion Criteria:

  • HIV positive females between 21-40 years of age.
  • Subjects must be receiving anti-HIV regimen consisting of tenofovir, emtricitabine, atazanavir, and ritonavir for a minimum of 4 weeks prior to the study.
  • Subjects must have regular menstrual cycle (period), define at least 10 cycles a year, occurring approximately every 28 days+/- 4 days and cycle length varying by not more than 7 days.

Exclusion Criteria:

  • Subjects can not be breast feeding, pregnant, or taking oral contraceptives (birth control pills) for at least 3 months prior to the study.
  • Subjects may not have the intrauterine device (IUD), Mirena, in place to prevent pregnancy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01394133

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

No publications provided

Responsible Party: Jennifer King, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01394133     History of Changes
Other Study ID Numbers: F10102815, 1K23AI074390-01A2
Study First Received: July 12, 2011
Last Updated: April 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
HIV Infected Women

ClinicalTrials.gov processed this record on March 03, 2015