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

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

sites

Clinical Trial Facility in Houston Texas

Houston, Texas

from

Houston, TX