Female Upper Genital Tract in HIV-infected Women (FUGTS)

University of North Carolina (UNC)

Status: Completed

Conditions: HIV

Treatments: Procedure: Endometrial biopsy

Study type: Observational

Funder types: Other

Identifiers

NCT02160392

FUGTS2010

Details and patient eligibility

About

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

Full 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.

Enrollment: 26 patients

Sex: Female

Ages: 25 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

26 participants in 1 patient group

Endometrial biopsy

Description:

HIV + and HIV negative women underwent lower and upper genital tract sampling.

Treatment:

Procedure: Endometrial biopsy