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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: Completed Phase 1 study of HIV Infections and HIV/AIDS, sponsored by University of North Carolina, Chapel Hill.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00855088 record still lists
NCT00855088 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (97% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for HIV Infections
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00855088's enrollment target sits among peer trials
13 518th of 542 higher than 25 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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