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

NCT00855088 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2011-05-13

No results posted yet for this 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

Interventions

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)

Sponsors & Collaborators

  • Tibotec Pharmaceutical Limited

    collaborator INDUSTRY

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Angela DM Kashuba, PharmD · UNC Eshelman School of Pharmacy

  • Kristine B Patterson, MD · University of North Carolina, Chapel Hill

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-02-28
Completion
2011-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00855088 on ClinicalTrials.gov