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Sex Hormone Therapy and Mucosal Tissues

NCT02983110 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2018-12-06

No results posted yet for this study

Summary

The purpose of this research study is to better understand how sex hormone therapy that is used to treat women for menopausal symptoms, men with low testosterone, or as hormone therapy for transgender women, affects a class of medications called NRTIs (nucleoside reverse transcriptase inhibitors) used to treat and prevent HIV infection. The two most commonly used NRTIs are tenofovir and emtricitabine, which are the components of the drug Truvada and also included in the combination products Atripla, Complera, and Stribild. The medication's ability to work effectively may be altered when someone is also taking sex hormone therapy.

In order to determine this effect, samples will be collected from some parts of the body where HIV makes copies. These samples will be measured for the levels of HIV medication, HIV virus and sex hormones that are present. The samples that will be looked at in this study include blood, cells from the vagina, semen, and tissue biopsies from the female genital tract and rectum.

Conditions

Interventions

PROCEDURE

Anoscopy with Rectal Tissue Sampling

All subjects will provide 10 pieces of rectal tissue

PROCEDURE

Phlebotomy

• Procedure: Blood plasma/serum collection Approximately 17 mL of blood will be taken from each subject just prior to tissue sampling.

PROCEDURE

Female Genital Tract Sampling

Cohorts B only will have cervical cells, cervical tissue, and vaginal tissue collected

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Mackenzie Cottrell, PharmD · UNC Chapel Hill

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2018-10-01
Completion
2018-10-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02983110 on ClinicalTrials.gov