Female Upper Genital Tract in HIV-infected Women

Completed

• Conditions: HIV
• Interventions: Procedure: Endometrial biopsy

• Registration Number: NCT02160392
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-06
• Study First Submitted: 2014-06-05
• Study First Submitted QC: 2014-06-06
• Last Update Submitted: 2014-06-06
• Study First Posted: 2014-06-10
• Last Update Posted: 2014-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 26

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Endometrial biopsy	Endometrial biopsy	HIV + and HIV negative women underwent lower and upper genital tract sampling.

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

UNC; 🇺🇸 Chapel Hill, North Carolina, United States