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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02160392
Recruitment Status : Completed
First Posted : June 10, 2014
Last Update Posted : June 10, 2014
Information provided by (Responsible Party):
Lisa Rahangdale, MD, MPH, University of North Carolina, Chapel Hill

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

Condition or disease Intervention/treatment
HIV Procedure: Endometrial biopsy

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.

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Study Type : Observational
Actual Enrollment : 26 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Virologic, Pharmacologic, and Immunologic Characterization of the Female Upper Genital Tract in HIV-infected Women
Study Start Date : May 2010
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy HIV/AIDS

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

Primary Outcome Measures :
  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).

Biospecimen Retention:   Samples Without DNA
Endometrial and cervical lavage specimens

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
We enrolled HIV-1 positive menstruating women between ages 25-48 years.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02160392

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United States, North Carolina
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
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Principal Investigator: Lisa Rahangdale, MD, MPH UNC Chapel Hill
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Responsible Party: Lisa Rahangdale, MD, MPH, Assistant Professor, University of North Carolina, Chapel Hill Identifier: NCT02160392    
Other Study ID Numbers: FUGTS2010
First Posted: June 10, 2014    Key Record Dates
Last Update Posted: June 10, 2014
Last Verified: June 2014
Keywords provided by Lisa Rahangdale, MD, MPH, University of North Carolina, Chapel Hill:
genital tract