Skip to main content
OpenTrials
Completed

NCT Number: NCT02160392

Female Upper Genital Tract in HIV-infected Women

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV

Age range

25 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

UNC

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

endometrial biopsy

Procedure

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.

Primary outcomes

  1. Immune characteristics

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

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

Acronym: FUGTS

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jun 10, 2014
Registry last updated
Jun 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.