Study in Healthy Males to Measure Darunavir and Etravirine in Blood, Seminal Fluid, and Rectal Tissue

NCT00855088 | Completed Phase 1

• 1 other identifier: UNC IRB 08-0419
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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

HIV/AIDS; HIV Infections

Keywords

HIV seronegativity

Outcome Measures

Primary Outcomes (2)

• To generate individual pharmacokinetic parameters for darunavir, ritonavir, and etravirine in seminal plasma after single and multiple dosing

  Study days 1, 7, and 8

• To generate composite pharmacokinetic parameters for darunavir, ritonavir, and etravirine in rectal tissue after single and multiple dosing

  Study days 1 and 7 or 8

Secondary Outcomes (1)

• To generate matrix:blood plasma ratios of darunavir, ritonavir, and etravirine in semen and rectal tissue after single and multiple dosing

  Study days 1, 7 and 8

Study Arms (1)

Darunavir, ritonavir, etravirine

EXPERIMENTAL

Single arm trial looking at the pharmacokinetics of darunavir, ritonavir, etravirine in healthy volunteers.

Drug: darunavir; Drug: Ritonavir; Drug: Etravirine

Interventions

darunavir DRUG

Healthy male volunteers will take darunavir 600 mg orally twice daily for 15 doses (8 days)

Also known as: Prezista

Darunavir, ritonavir, etravirine

Ritonavir DRUG

Healthy male volunteers will take ritonavir 100 mg orally twice daily for 15 doses (8 days)

Also known as: Norvir

Darunavir, ritonavir, etravirine

Etravirine DRUG

Healthy male volunteers will take etravirine 200 mg orally twice daily for 15 doses (8 days)

Also known as: Intelence

Darunavir, ritonavir, etravirine

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects between the ages of 18 and 49 years, inclusive, with intact genital tract and gastrointestinal tract. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG for individuals \>35yo and clinical laboratory tests).
• Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight \>/=50 kg (110 lbs).
• Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.
• Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.

You may not qualify if:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
• Subjects with a history of having a gastrectomy, colostomy, ileostomy, or any other procedure altering the gastrointestinal tract.
• Subjects with inflammatory bowel diseases (ulcerative colitis or Crohn's disease) and have a clearly defined diagnosis of irritable bowel syndrome.
• Subject who is unwilling to refrain from any sexual activity including intercourse and masturbation for 72 hours prior study visit Day 1 and until discharge from the study.
• Subject who is unwilling to refrain from rectal insertion of medical/recreation devices and products and from receptive anal intercourse, for 72 hours before study visit Day -1 and through 7 days after the last biopsy unless instructed otherwise by the investigators.
• History of febrile illness within 5 days prior to the first dose.
• Any condition possibly affecting drug absorption (eg, gastrectomy).
• A positive urine drug screen.
• A positive result for HIV.
• Active hepatitis B infection as defined by a positive Hepatitis B surface antigen (HbsAg) OR a positive Hepatitis B core antibody with a negative Hepatitis B surface antibody (HBsAb).
• Active hepatitis C infection as defined by anti-hepatitis C virus serology (as determined by multi-antigen EIA) and detectable HCV RNA.
• A positive test for syphilis, gonorrhea, Chlamydia, HSV-2 (active lesions) or trichomonas at screening.
• History of regular alcohol consumption exceeding 14 drinks (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of spirits) per week.
• Participation in a clinical study within 4 months preceding the first dose of trial medication.
• Participation in a rectal biopsy study in the 12 months preceding the first dose of trial medication.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Tibotec Pharmaceutical Limited: collaborator

Study Sites (1)

UNC Hospitals CTRC

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; HIV Infections

Interventions

Darunavir; Ritonavir; etravirine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Sulfones; Sulfur Compounds; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Azoles

Study Officials

• Angela DM Kashuba, PharmD

  UNC Eshelman School of Pharmacy

  PRINCIPAL INVESTIGATOR

• Kristine B Patterson, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 2, 2009
• First Posted: March 4, 2009
• Study Start: July 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2011
• Last Updated: May 13, 2011

Record last verified: 2011-05

Locations

US (1)