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NCT02218320 · ClinicalTrials.gov registry record
Comparison of Virologic and Immunologic Responses to Raltegravir and Dolutegravir in the Gastrointestinal Tract of HIV-Positive Adults
A clinical trial, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- 20
- Enrollment target
NCT02218320 is a clinical trial that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 20 participants.
The verdict
NCT02218320 has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- 20 participants
- Enrollment target
Study Summary
This is a Phase IV, open label, observational study to compare the gastrointestinal tissue concentrations, inflammatory response, and viral replication of two integrase-inhibitors, raltegravir and dolutegravir, in HIV-infected volunteers who are virologically suppressed in blood plasma. The study will be comprised of 20 HIV-infected volunteers who will be enrolled equally into two groups. Group A will consist of 10 subjects receiving an antiretroviral regimen of tenofovir, emtricitabine, and raltegravir, and Group B will consist of 10 subjects receiving an antiretroviral regimen of tenofovir, emtricitabine, and dolutegravir. Participants will provide small pieces of tissue, or biopsies, which will be taken from three distinct locations of the large intestine during a colonoscopy procedure. These biopsies will be used to measure the amount of raltegravir or dolutegravir, HIV virus, and inflammatory markers present in the gastrointestinal tract.
Interventions
- DRUG Dolutegravir
- DRUG Raltegravir
- PROCEDURE Colonoscopy with biopsy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2014-10 |
| Est. Completion | 2015-10 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02218320
The ClinicalTrials.gov registry entry for NCT02218320 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Dolutegravir is the first listed.
NCT02218320 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02218320 about?
NCT02218320 is a clinical study titled "Comparison of Virologic and Immunologic Responses to Raltegravir and Dolutegravir in the Gastrointestinal Tract of HIV-Positive Adults". This is a Phase IV, open label, observational study to compare the gastrointestinal tissue concentrations, inflammatory response, and viral replication of two integrase-inhibitors, raltegravir and dolutegravir, in HIV-infected volunteers who are virologically suppressed in blood plasma. The study wi...
What is the current status of trial NCT02218320?
This trial is currently completed. The enrollment target is 20 participants. The study started on 2014-10. Estimated completion is 2015-10.
What interventions are being tested in trial NCT02218320?
The interventions under investigation include: Dolutegravir (DRUG), Raltegravir (DRUG), Colonoscopy with biopsy (PROCEDURE).
Who is sponsoring clinical trial NCT02218320?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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