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

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ClinicalTrials.gov Identifier: NCT01394133
Recruitment Status : Withdrawn (Lack of enrollment)
First Posted : July 14, 2011
Last Update Posted : April 30, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
HIV Infected Drug: Tenofovir, Emtricitabine, Atazanavir, Ritonavir

Study Design

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Menstrual Cycle on Antiretroviral Pharmacokinetics in HIV-Infected Women
Study Start Date : July 2011
Primary Completion Date : April 2013
Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :
  1. PK parameters [ Time Frame: 28 days ]
    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

Eligibility Criteria

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Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes 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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01394133

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

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 ( U.S. NIH Grant/Contract )
First Posted: July 14, 2011    Key Record Dates
Last Update Posted: April 30, 2013
Last Verified: April 2013

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

Additional relevant MeSH terms:
Atazanavir Sulfate
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors