Female Upper Genital Tract in HIV-infected Women

Study Overview
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Brief Summary
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The female upper genital tract is a unique compartment involved in HIV pathogenesis.

Detailed Description
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The persistent detection of HIV in the female genital tract in spite of ART is unexplained, and it is possible the uterine endometrium serve as a reservoir. There are limited data regarding the interaction between HIV expression, antiretroviral therapy (ART) and host immune system in the uterine endometrium.

Official Title
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Virologic, Pharmacologic, and Immunologic Characterization of the Female Upper Genital Tract in HIV-infected Women

Conditions
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HIV

Intervention / Treatment
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* Procedure: Endometrial biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Regularly menstruating women (between 21-42 days) between ages 25-50 years Fully suppressed by antiretroviral therapy with plasma HIV RNA < 40 copies/mL within the last 6 months. Exclusion Criteria: Pregnant or planning pregnancy Unwilling to use 2 forms of contraception (condoms + hormonal) if they did not have previous bilateral tubal ligation procedure Intrauterine device in place Untreated cervical infection (N. gonnorhea, C. trachomatis) Taking immunosuppressive medications

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Endometrial biopsy<br>HIV + and HIV negative women underwent lower and upper genital tract sampling. | Procedure: Endometrial biopsy<br>* Endometrial biopsy (EMB) specimens were collected via a 3 mm diameter plastic pipelle that was inserted into the uterus following EML. A sample of tissue was obtained by retracting the pipelle's plunger leading to negative suction and rotating the cannula for approximately 15 seconds.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immune characteristics | Endometrial lavage (EML) and biopsy (EMB) samples were compared to cervicovaginal lavage (CVL) and fluid (CVF) samples from HIV-negative healthy women (N=x) and HIV-infected women (n=x) taking ART with plasma HIV RNA <40 copies/mL. All participants were in the luteal phase of the menstrual cycle. Immunologic study was completed using Luminex and flow cytometry. Concentrations of tenofovir (TFV), emtricitabine (FTC) and their active intracellular metabolites (TFVdp and FTCtp) were measured using LC-MS/MS in 11 HIV-infected women. HIV RNA was measured in plasma, EML and CVL using the Abbott RealTime HIV-1 assay (lower limit of detection 40 copies/mL). | Single visit approximately 14-42 days after the first day of the last menstrual period. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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female, genital tract, HIV