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Antiretroviral Localization in Gut-Associated Lymphoid Tissue and Lower Female Genital Tract Tissue of HIV+ Subjects

NCT02641444 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 5

Last updated 2018-01-17

No results posted yet for this study

Summary

The purpose of this research study is to find out how the drugs Truvada® (tenofovir/emtricitabine), Isentress® (raltegravir), Reyataz® (atazanavir), Sustiva® (efavirenz), and Selzentry® (maraviroc) get into the intestines and the female genital tract. All of these drugs are very effective at reducing the number of HIV viruses in the blood, however it is unknown how the drugs move around inside tissues where HIV might be hiding. This study will determine specifically where in the tissue the drug and the HIV are located through the use of a new technology that takes creates a picture of the tissue. This information will help scientists determine the best way to make new drugs to target the hidden HIV in tissue.

Conditions

Interventions

PROCEDURE

Blood plasma collection

Approximately 3mL of blood will be taken from each subject just prior to the colonoscopy.

PROCEDURE

Cervical and Vaginal Biopsy

2 biopsies each will be collected from the vaginal wall and the cervix

PROCEDURE

Colonoscopy with Ileal and Rectal Biopsy

10 biopsies each will be collected from the rectum and terminal ileum from each subject during the colonoscopy.

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Angela DM Kashuba, PharmD · University of North Carolina, Chapel Hill

Eligibility

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

Timeline & Regulatory

Start
2016-04-13
Primary Completion
2017-08-29
Completion
2017-08-29

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 NCT02641444 on ClinicalTrials.gov