Female Upper Genital Tract in HIV-infected Women (FUGTS)
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|ClinicalTrials.gov Identifier: NCT02160392|
Recruitment Status : Completed
First Posted : June 10, 2014
Last Update Posted : June 10, 2014
|Condition or disease||Intervention/treatment|
|HIV||Procedure: Endometrial biopsy|
|Study Type :||Observational|
|Actual Enrollment :||26 participants|
|Observational Model:||Case Control|
|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|
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.
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT02160392
|United States, North Carolina|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Lisa Rahangdale, MD, MPH||UNC Chapel Hill|