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| Sponsor: | University of North Carolina, Chapel Hill |
|---|---|
| Collaborator: |
Tibotec Pharmaceutical Limited |
| Information provided by: | University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT00855088 |
Purpose
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 |
|---|---|---|
|
HIV/AIDS HIV Infections |
Drug: darunavir Drug: Ritonavir Drug: Etravirine |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| 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 |
| Enrollment: | 13 |
| Study Start Date: | July 2009 |
| Study Completion Date: | February 2011 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Darunavir, ritonavir, etravirine
Single arm trial looking at the pharmacokinetics of darunavir, ritonavir, etravirine in healthy volunteers.
|
Drug: darunavir
Healthy male volunteers will take darunavir 600 mg orally twice daily for 15 doses (8 days)
Other Name: Prezista
Drug: Ritonavir
Healthy male volunteers will take ritonavir 100 mg orally twice daily for 15 doses (8 days)
Other Name: Norvir
Drug: Etravirine
Healthy male volunteers will take etravirine 200 mg orally twice daily for 15 doses (8 days)
Other Name: Intelence
|
Eligibility| Ages Eligible for Study: | 18 Years to 49 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 | University of North Carolina, Chapel Hill |
More Information
| Responsible Party: | Angela Kashuba, PharmD, UNC Chapel Hill Eshelman School of Pharmacy |
| ClinicalTrials.gov Identifier: | NCT00855088 History of Changes |
| Other Study ID Numbers: | UNC IRB 08-0419 |
| Study First Received: | March 2, 2009 |
| Last Updated: | May 11, 2011 |
| Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
|
HIV seronegativity |
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Ritonavir |
Darunavir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |