A Study Comparing the Efficacy and Safety of Once-Daily Fuzeon (Enfuvirtide) Dosing Versus the Currently Recommended Twice-Daily Dosing in Human Immunodeficiency Virus-Type 1 (HIV-1) Infected Patients



Status:Completed
Conditions:HIV / AIDS, HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:16 - Any
Updated:8/3/2016
Start Date:July 2004
End Date:June 2006

Use our guide to learn which trials are right for you!

A Phase II Open-label, Randomized, Active-controlled Study Comparing the Efficacy and Safety of Once Daily Enfuvirtide Dosing Versus the Currently Recommended Twice Daily Dosing in HIV-1 Infected Treatment-experienced Patients.

This study will assess the safety and efficacy of once-daily administration of Fuzeon
compared with twice-daily administration in HIV-1 infected patients who have received prior
treatment. Patients will also receive an optimized treatment consisting of antiretroviral
(ARV) therapy as determined by the treating physician. The anticipated time on study
treatment is 3-12 months, and the target sample size is 100-500 individuals.


Inclusion Criteria:

- HIV-1 infected adults or adolescents >=16 years of age;

- HIV-1 RNA >=5000 copies/mL;

- prior experience or documented resistance to each of the 3 currently available
classes of ARV drugs (nucleoside reverse transcriptase inhibitors, non-nucleoside
reverse transcriptase inhibitors, and protease inhibitors).

Exclusion Criteria:

- history of prior use of Fuzeon or T-1249;

- female patients who are pregnant or breastfeeding, or who plan to become pregnant
during the study;

- current severe illness;

- currently taking drugs affecting the immune system, HIV vaccine, or investigational
agents for any conditions other than HIV/AIDS.
We found this trial at
20
sites
?
mi
from
Denver, CO
Click here to add this to my saved trials
?
mi
from
Albany, NY
Click here to add this to my saved trials
?
mi
from
Allentown, PA
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Austin, TX
Click here to add this to my saved trials
?
mi
from
Boston, MA
Click here to add this to my saved trials
?
mi
from
Bradenton, FL
Click here to add this to my saved trials
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Fountain Valley, California 92708
?
mi
from
Fountain Valley, CA
Click here to add this to my saved trials
?
mi
from
Hobson City, AL
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
North Miami Beach, Florida 33162
?
mi
from
North Miami Beach, FL
Click here to add this to my saved trials
?
mi
from
Orlando, FL
Click here to add this to my saved trials
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
?
mi
from
Sarasota, FL
Click here to add this to my saved trials
?
mi
from
Toronto,
Click here to add this to my saved trials
?
mi
from
Union, NJ
Click here to add this to my saved trials