Female Upper Genital Tract in HIV-infected Women

HIV Clinical Trial

— FUGTS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02160392
• Other study ID #: FUGTS2010
• Status: Completed
• Phase: N/A
• First received: June 5, 2014
• Last updated: June 6, 2014
• Start date: May 2010
• Est. completion date: March 2014

Study information

• Verified date: June 2014
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 50 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• HIV

Intervention

Procedure:
• Endometrial 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.

Locations

Country	Name	City	State
United States	UNC	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No