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NCT00855088 · ClinicalTrials.gov registry record · Phase 1
Study in Healthy Males to Measure Darunavir and Etravirine in Blood, Seminal Fluid, and Rectal Tissue
A Phase 1 study of HIV Infections and HIV/AIDS, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
- 1
- Study location
NCT00855088 is a Phase 1 study of HIV Infections and HIV/AIDS that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 13 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00855088, a Phase 1 study of HIV Infections and HIV/AIDS, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is being conducted to look at how the body handles the drugs darunavir and etravirine. It will measure the amount of darunavir and etravirine in blood, semen, and in the rectum of men. The aim is to understand how much of the drug (taken by mouth) reaches the reproductive and intestinal tracts. It is believed that the presence of this drug in these areas may be beneficial in preventing the AIDS virus (HIV) from being passed from one person to another. The study will take samples of blood, semen and rectal mucosal tissue to measure drug levels. This study will also collect information on side effects.
Conditions Studied
Interventions
- DRUG Ritonavir
- DRUG Etravirine
- DRUG darunavir
Study Locations (1)
North Carolina
- UNC Hospitals CTRC - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2009-07 |
| Est. Completion | 2011-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00855088
The ClinicalTrials.gov registry entry for NCT00855088 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (97% lower). 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 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 3 interventions - of which Ritonavir is the first listed.
NCT00855088 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT00855088 about?
NCT00855088 is a clinical study titled "Study in Healthy Males to Measure Darunavir and Etravirine in Blood, Seminal Fluid, and Rectal Tissue". This study is being conducted to look at how the body handles the drugs darunavir and etravirine. It will measure the amount of darunavir and etravirine in blood, semen, and in the rectum of men. The aim is to understand how much of the drug (taken by mouth) reaches the reproductive and intestinal t...
What is the current status of trial NCT00855088?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2009-07. Estimated completion is 2011-02.
What conditions does trial NCT00855088 study?
This clinical trial studies the following conditions: HIV Infections, HIV/AIDS.
What interventions are being tested in trial NCT00855088?
The interventions under investigation include: Ritonavir (DRUG), Etravirine (DRUG), darunavir (DRUG).
Who is sponsoring clinical trial NCT00855088?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00855088 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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