HIV
Conditions
Keywords
HIV, female, genital tract
Brief summary
The female upper genital tract is a unique compartment involved in HIV pathogenesis.
Detailed description
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.
Interventions
PROCEDUREEndometrial biopsy
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.
Sponsors
University of North Carolina, Chapel Hill
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immune characteristics | Single visit approximately 14-42 days after the first day of the last menstrual period. | 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). |
Countries
United States
Outcome results
None listed