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| Name | Class |
|---|---|
| American College of Clinical Pharmacy | OTHER |
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Cervical biopsies will be collected from women aged 18 and over whom are virally suppressed and taking tenofovir as part of their antiretroviral therapy regimen. Blood plasma, peripheral blood mononuclear cells (PBMC), and cervicovaginal swabs will also be collected. Drug concentrations, hormone concentrations, inflammatory cytokines, and vaginal microbiome will be evaluated to understand the role of hormones, inflammation, and the microbiome in modulating drug efficacy in the female genital tract.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenofovir | Drug | Two cervical biopsies, blood plasma, PBMC, and two cervicovaginal swabs will be collected at a single study visit | ||
| Emtricitabine | Drug | Two cervical biopsies, blood plasma, PBMC, and two cervicovaginal swabs will be collected at a single study visit |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the influence of exogenous and endogenous sex hormones on tenofovir and emtricitabine concentrations in cervical tissues | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the influence of endogenous and exogenous sex hormones on the expression of drug metabolizing enzymes and transporters in cervical tissue | Day 1 | |
| To determine the influence of endogenous and exogenous sex hormones on the endogenous nucleotide pool in cervical tissues |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D014627 | Vaginitis |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| D000068679 | Emtricitabine |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
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| Day 1 |
| To discriminate between local and systemic effects of hormonal use on antiretroviral disposition. | Day 1 |
| To determine relationship between local inflammation and drug disposition in the female genital tract | Day 1 |
| To identify potential role of the vaginal microbiome in local drug disposition, | Day 1 |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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 |