An observational study in HIV Infected, sponsored by University of Alabama at Birmingham. Withdrawn at 1 site in United States. Open to female participants aged 21 Years to 40 Years. Per ClinicalTrials.gov, last updated 2013-04-30.
Sponsored by University of Alabama at Birmingham · Observational
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.
University of Alabama at Birmingham is the lead sponsor of 1,416 studies on the registry; 278 are open to participants now.
Of its 160 completed or terminated interventional studies of FDA-regulated products, 128 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
HIV-infected women will be selected from the primary care office
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Exclusion Criteria:
HIV infected women between 21-40 years of age, not receiving oral contraceptives.
Drug: Tenofovir, Emtricitabine, Atazanavir, Ritonavir
Drug pages: 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.
PK parameters
The area under the concentration time curve and minimum concentration for tenofovir, emtricitabine, atazanavir and ritonavir
Time frame: 28 days
The record gives a start of Jul 2011, a primary completion of Apr 2013 and a completion of Apr 2013. It does not say whether these dates are actual or estimated.
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This study is withdrawn, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
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University of Alabama at Birmingham →