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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23AI074390-01A2 | U.S. NIH Grant/Contract | View source |
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Lack of enrollment
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV+ Female | HIV infected women between 21-40 years of age, not receiving oral contraceptives. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenofovir, Emtricitabine, Atazanavir, Ritonavir | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters | The area under the concentration time curve and minimum concentration for tenofovir, emtricitabine, atazanavir and ritonavir | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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HIV-infected women will be selected from the primary care office
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
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| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| D000068679 | Emtricitabine |
| D000069446 | Atazanavir Sulfate |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
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5 mL of plasma
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D011725 | Pyridines |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |