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

This study has been withdrawn prior to enrollment.

(Lack of enrollment)

Sponsor:

ClinicalTrials.gov Identifier:

NCT01394133

First Posted: July 14, 2011

Last Update Posted: April 30, 2013

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

National Institute of Allergy and Infectious Diseases (NIAID)

Information provided by (Responsible Party):

Jennifer King, University of Alabama at Birmingham

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:

MedlinePlus related topics: HIV/AIDS Menstruation

Drug Information available for: Emtricitabine Tenofovir Ritonavir Atazanavir

U.S. FDA Resources

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

Primary Outcome Measures:

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


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

Information from the National Library of Medicine

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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

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

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

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


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 Submitted:	July 12, 2011
First Posted:	July 14, 2011
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:


Ritonavir Atazanavir Sulfate Tenofovir Emtricitabine 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

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