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

This study has been withdrawn prior to enrollment.
(Lack of enrollment)
Sponsor:
Collaborator:
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

July 12, 2011
April 29, 2013
July 2011
April 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01394133 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Impact of Menstrual Cycle on Antiretroviral Pharmacokinetics in HIV-Infected Women
Impact of Menstrual Cycle on Antiretroviral Pharmacokinetics in HIV-Infected Women

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

5 mL of plasma

Non-Probability Sample

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

HIV Infected
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.
HIV+ Female
HIV infected women between 21-40 years of age, not receiving oral contraceptives.
Intervention: Drug: Tenofovir, Emtricitabine, Atazanavir, Ritonavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
April 2013
April 2013   (final data collection date for primary outcome measure)

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.
Female
21 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01394133
F10102815, 1K23AI074390-01A2
Yes
Jennifer King, University of Alabama at Birmingham
University of Alabama at Birmingham
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
University of Alabama at Birmingham
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP