Female Upper Genital Tract in HIV-infected Women

University of North Carolina, Chapel Hill26 enrolled

Overview

The female upper genital tract is a unique compartment involved in HIV pathogenesis.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

HIV

Interventions

Endometrial biopsyPROCEDURE

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.

Eligibility

Sex: FEMALEMin age: 25 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

UNC

Chapel Hill, North Carolina, United States

Outcomes

Primary Outcomes

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).

Time frame: Single visit approximately 14-42 days after the first day of the last menstrual period.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.