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Sponsors and Collaborators: |
The University of North Carolina, Chapel Hill Tibotec Pharmaceutical Limited |
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Information provided by: | The University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT00855088 |
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.
Condition | Intervention | Phase |
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HIV/AIDS HIV Infections |
Drug: darunavir Drug: Ritonavir Drug: Etravirine |
Phase IV |
Study Type: | Interventional |
Study Design: | Basic Science, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study |
Official Title: | A Phase IV, Open Label Study in Healthy Male Subjects to Investigate the Extent of Darunavir/Ritonavir and Etravirine Exposure in Blood, Seminal Fluid, and Rectal Mucosal Tissue Following Single and Multiple Dosing of Darunavir/Ritonavir and Etravirine |
Estimated Enrollment: | 12 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Darunavir, ritonavir, etravirine: Experimental
Single arm trial looking at the pharmacokinetics of darunavir, ritonavir, etravirine in healthy volunteers.
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Drug: darunavir
Healthy male volunteers will take darunavir 600 mg orally twice daily for 15 doses (8 days)
Drug: Ritonavir
Healthy male volunteers will take ritonavir 100 mg orally twice daily for 15 doses (8 days)
Drug: Etravirine
Healthy male volunteers will take etravirine 200 mg orally twice daily for 15 doses (8 days)
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Ages Eligible for Study: | 18 Years to 49 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kevin C Brown, PharmD | 919-962-0029 | kcb@unc.edu |
United States, North Carolina | |
UNC Hospitals CTRC | |
Chapel Hill, North Carolina, United States, 27514 |
Principal Investigator: | Angela DM Kashuba, PharmD | UNC Eshelman School of Pharmacy |
Principal Investigator: | Kristine B Patterson, MD | The University of North Carolina, Chapel Hill |
Responsible Party: | UNC Chapel Hill Eshelman School of Pharmacy ( Angela Kashuba, PharmD ) |
Study ID Numbers: | UNC IRB 08-0419 |
Study First Received: | March 2, 2009 |
Last Updated: | April 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00855088 History of Changes |
Health Authority: | United States: Food and Drug Administration |
HIV seronegativity |
Sexually Transmitted Diseases, Viral HIV Protease Inhibitors Anti-HIV Agents Acquired Immunodeficiency Syndrome Healthy Antiviral Agents Immunologic Deficiency Syndromes Darunavir |
Protease Inhibitors Virus Diseases Anti-Retroviral Agents HIV Infections Ritonavir Sexually Transmitted Diseases Retroviridae Infections |
Anti-Infective Agents HIV Protease Inhibitors RNA Virus Infections Sexually Transmitted Diseases, Viral Anti-HIV Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Infection Antiviral Agents |
Pharmacologic Actions Darunavir Immunologic Deficiency Syndromes Protease Inhibitors Virus Diseases Anti-Retroviral Agents HIV Infections Ritonavir Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |