Female Upper Genital Tract in HIV-infected Women
FUGTS
Virologic, Pharmacologic, and Immunologic Characterization of the Female Upper Genital Tract in HIV-infected Women
1 other identifier
observational
26
1 country
1
Brief Summary
The female upper genital tract is a unique compartment involved in HIV pathogenesis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2010
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 5, 2014
CompletedFirst Posted
Study publicly available on registry
June 10, 2014
CompletedJune 10, 2014
June 1, 2014
3.8 years
June 5, 2014
June 6, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (1)
Endometrial biopsy
HIV + and HIV negative women underwent lower and upper genital tract sampling.
Interventions
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.
Eligibility Criteria
We enrolled HIV-1 positive menstruating women between ages 25-48 years.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UNC
Chapel Hill, North Carolina, 27599, United States
Biospecimen
Endometrial and cervical lavage specimens
Study Officials
- PRINCIPAL INVESTIGATOR
Lisa Rahangdale, MD, MPH
UNC Chapel Hill
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 5, 2014
First Posted
June 10, 2014
Study Start
May 1, 2010
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
June 10, 2014
Record last verified: 2014-06