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

This study has been completed.

Sponsors and Collaborators:	Hoffmann-La Roche Trimeris
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00089492

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: enfuvirtide [Fuzeon] Drug: Optimized Background ARVs	Phase II

MedlinePlus related topics: AIDS

Drug Information available for: Enfuvirtide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	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.

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Viral load. [ Time Frame: Week 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

CD4 lymphocyte count. [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
AEs, laboratory abnormalities, local injection site reactions, AIDS-defining events. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:

Arms	Assigned Interventions
1: Experimental	Drug: enfuvirtide [Fuzeon] 180mg sc once daily for 48 weeks Drug: Optimized Background ARVs As prescribed
2: Active Comparator	Drug: enfuvirtide [Fuzeon] 90mg sc bid for 48 weeks Drug: Optimized Background ARVs As prescribed

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00089492

Show 27 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Trimeris

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Publications indexed to this study:

Wright D, Rodriguez A, Godofsky E, Walmsley S, Labriola-Tompkins E, Donatacci L, Shikhman A, Tucker E, Chiu YY, Chung J, Rowell L, Demasi R, Graham N, Salgo M. Efficacy and safety of 48 weeks of enfuvirtide 180 mg once-daily dosing versus 90 mg twice-daily dosing in HIV-infected patients. HIV Clin Trials. 2008 Mar-Apr;9(2):73-82.

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	NV17658
Study First Received:	August 5, 2004
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00089492
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Enfuvirtide
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Anti-HIV Agents
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Infection

Antiviral Agents
Pharmacologic Actions
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
HIV Fusion Inhibitors

ClinicalTrials.gov processed this record on January 14, 2009