Female Upper Genital Tract in HIV-infected Women

NCT ID: NCT02160392

Last Updated: 2014-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2014-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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HIV

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Endometrial biopsy

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

Endometrial biopsy

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Lisa Rahangdale, MD, MPH

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lisa Rahangdale, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

UNC Chapel Hill

Locations

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UNC

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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FUGTS2010

Identifier Type: -

Identifier Source: org_study_id

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