drugset / Trial / NCT00855088
Study in Healthy Males to Measure Darunavir and Etravirine in Blood, Seminal Fluid, and Rectal Tissue
Phase 1
Completed
13 enrolled
University of North Carolina, Chapel Hill
Tibotec Pharmaceutical Limited · collab
Non-randomizedSingle-groupOpen-labelBasic science
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.
Timeline
- Start
- 2009-07
- Primary completion
- 2010-02
- Completion
- 2011-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Darunavir | Small molecule | 600 mg | Oral |
| Subject | Etravirine | Small molecule | 200 mg | Oral |
| Subject | Ritonavir | Other / unclassified | 100 mg | Oral |